Effect of Expiration or Termination. (a) Upon expiration of the License Term, all of the following will apply: (i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable; (ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2; (iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement; (iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement; (v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion. (vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3 (b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply: (i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it. (ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka. (iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion. (iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it. (v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same. (c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply: (i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect. (ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it. (iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory. (iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals. (d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product. (e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder. (f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.
Appears in 3 contracts
Samples: Development and License Agreement (Gw Pharmaceuticals PLC), Development and License Agreement (Gw Pharmaceuticals PLC), Development and License Agreement (Gw Pharmaceuticals PLC)
Effect of Expiration or Termination. (a) Upon expiration of the License TermTerm of this Agreement, all Xxxxxx shall be permitted to sell off any inventory of Generic Product in its possession as of the following will applydate of expiration.
(b) Upon termination of this Agreement by Salix pursuant to Section 11.2(a) or by Xxxxxx pursuant to Section 11.8:
(i) Xxxxxx immediately shall cease all sales, marketing and distribution of the Generic Product and Xxxxxx shall immediately destroy any inventory of Generic Product under its control, at its expense, and shall either, at Salix’s option, (A) allow a Salix representative to be present during such destruction or (B) provide a certificate of such destruction.
(ii) All then outstanding Firm Orders automatically shall be cancelled.
(iii) Xxxxxx promptly shall reimburse Salix for all actual and reasonable costs incurred by Salix to complete activities associated with the termination of this Agreement, including, without limitation (A) the costs of all Materials purchased by Salix up to the effective date of termination which cannot be diverted to Salix’s other uses and which are non-refundable and (B) the Purchase Price for any finished Generic Product and the cost of any work in process which cannot be diverted to Salix’s other uses held by Salix as of the effective date of termination and Manufactured by Salix in accordance with Firm Orders then outstanding. [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.
(iv) To the extent any amount reimbursable by Salix pursuant to Section 3.1(b) has not been reimbursed by Salix or credited against Profits payable by Xxxxxx as of the date of termination, Salix shall reimburse such amount to Xxxxxx within sixty (60) days after the date of termination.
(c) Upon termination of this Agreement by Salix pursuant to Section 11.2(b) or (c):
(i) Xxxxxx shall be permitted to sell off any inventory of Generic Product in its possession as of the date of termination.
(ii) All then outstanding Firm Orders automatically shall be cancelled.
(iii) Xxxxxx promptly shall reimburse Salix for all actual and reasonable costs incurred by Salix to complete activities associated with the termination of this Agreement, including, without limitation (A) the costs of all Materials purchased by Salix up to the effective date of termination which cannot be diverted to Salix’s other uses and which are non-refundable and (B) the Purchase Price for any finished Generic Product and the cost of any work in process which cannot be diverted to Salix’s other uses held by Salix as of the effective date of termination and Manufactured by Salix in accordance with Firm Orders then outstanding.
(d) Upon termination of this Agreement by Salix pursuant to Section 11.2(d):
(i) All then outstanding Firm Orders automatically shall be cancelled.
(ii) Xxxxxx immediately shall cease all sales, marketing and distribution of the Generic Product and Salix promptly shall repurchase all saleable inventory of the Generic Product held by Xxxxxx as of the date of termination at the Purchase Price paid for such Generic Product, and Xxxxxx shall deliver such Generic Product to Salix at Salix’s expense.
(e) Upon termination of this Agreement by Xxxxxx pursuant to Section 11.3 or by Salix pursuant to Section 11.8:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement then outstanding Firm Orders automatically shall be deemed to be paid-up and irrevocable;cancelled.
(ii) GW Pharma shall, at Otsuka’s election, continue Xxxxxx shall be permitted to supply Licensed Products to Otsuka on the terms sell off any inventory of Generic Product in its possession as of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;date of termination.
(iii) Otsuka shall be entitled to require To the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma extent any amount reimbursable by Otsuka Salix pursuant to Section 2.3 3.1(b) has not been reimbursed by Salix or credited against Profits payable by Xxxxxx as of the date of termination, Salix shall reimburse such amount to Xxxxxx within sixty (60) days after the date of termination.
(f) Upon termination of this Agreement by Salix pursuant to Section 11.2(f) or 11.4(a):
(i) All then outstanding Firm Orders automatically shall continue for be cancelled; provided that, if on the term date of termination Xxxxxx holds less than [*] months’ of inventory of the Manufacturing Generic Product (determined based on the average monthly amount of Generic Product sold by Xxxxxx and Supply its Affiliates during the [*] full month-period prior to the date of termination), then, at Xxxxxx’x option, Salix will fulfill, in accordance with the terms of this Agreement so long as and such Firm Orders, that portion of any outstanding Firm Orders necessary to supply Xxxxxx a quantity of Generic Product equal to the Manufacturing difference between [*] months’ inventory and Supply Agreement is not terminated the quantity of Generic Product actually held by Otsuka or manufacture Xxxxxx on the date of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretiontermination.
(viii) The license Xxxxxx shall be permitted a sell-off period of [*] days to sell off any inventory of Generic Product in its possession as of the date of termination. Xxxxxx immediately shall cease all sales, marketing and associated rights granted distribution of the Generic Product at the end of such selloff period and Salix promptly shall repurchase all saleable inventory of the Generic Product held by Otsuka Xxxxxx as of the end of such selloff period at the Purchase Price paid by Xxxxxx for such Generic Product, and Xxxxxx shall deliver such Generic Product to GW Pharma Salix at Salix’s expense.
(g) Upon termination of this Agreement by Salix pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply11.5:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) then outstanding Firm Orders automatically shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to itcancelled.
(ii) GW Pharma shallXxxxxx immediately shall cease all sales, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms marketing and distribution of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of OtsukaGeneric Product.
(iii) In its sole discretion Otsuka Salix promptly shall have repurchase (A) all saleable inventory of the right Generic Product held by Xxxxxx as of the date of termination and (B) all Generic Product recovered by Xxxxxx from customers in accordance with subsection (iv) below, in each case at the Purchase Price paid for such Generic Product, and Xxxxxx shall deliver such Generic Product to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW PharmaSalix at Salix’s discretionexpense.
(iv) The license granted Under the direction of Salix, Xxxxxx shall, at Salix’s expense (excluding any refunds to customers, which shall be paid by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license[*] Confidential treatment requested; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been certain information omitted pursuant to a request for Confidential Treatment and filed separately with the CommissionSEC. comparable Xxxxxx and taken into account in the calculation of Net Sales), use its best efforts to recover all Generic Product which has been delivered to Xxxxxx but is no longer within Xxxxxx’x control, other than such Generic Product that set forth in has been consumed; provided that if any refunds paid to a customer by Xxxxxx under this Section 1.58. GW Pharma 11.8(g)(iv) would reduce the Profits for any period with respect to which a payment of Profits had already been made by Xxxxxx to Salix pursuant to Section 3.2, Salix promptly shall pay to Xxxxxx the amount necessary such that the proper allocation of Profits for such period pursuant to Section 3.1, taking into account such refunds, shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to itachieved.
(vh) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations Upon termination of the same.
(c) If this Agreement is terminated by GW Pharma either party pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply11.6:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement All then outstanding Firm Orders automatically shall terminate and be of no further force or effectcancelled.
(ii) The license granted by Otsuka Xxxxxx immediately shall cease all sales, marketing and distribution of the Generic Product and Xxxxxx shall immediately destroy any inventory of Generic Product under its control and shall either, at Salix’s option, (i) allow a Salix representative to GW Pharma under Section 2.3 be present during such destruction or (ii) provide a certificate of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to itsuch destruction.
(iii) Notwithstanding any other provision Salix shall bear [*]% and Xxxxxx shall bear [*]% of all actual and reasonable costs incurred by the parties to complete activities associated with the termination of this Section 10.7(c)Agreement, Otsuka and its sublicensees shall have including, without limitation, (A) the right and license in the Field to sell, offer for sale, have sold, import and export costs of all existing inventories of each Licensed Product then under their control for Materials purchased by Salix up to six the effective date of termination which cannot be diverted to Salix’s other uses and which are non-refundable, (6B) months following the cost of any Generic Product and any work in process which cannot be diverted to Salix’s other uses held by Salix as of the effective date of termination and Manufactured by Salix in accordance with Firm Orders then outstanding, and (C) the Purchase Price paid by Xxxxxx for any Generic Product held by Xxxxxx as of the date of termination, subject . Each party shall use Commercially Reasonable Efforts to minimize the continuing application costs it incurs to complete activities associated with the termination of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventoryAgreement.
(iv) Commensurate with then current legislative Each party acknowledges and regulatory requirements Otsuka agrees that the other party shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion have no liability of any dispute resolution procedure pursuant kind to such first party, other than as provided in this Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i11.9(h), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not under Section 11.6. [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.
(i) affect Upon termination of this Agreement by Salix pursuant to Section 11.2(e):
(i) All then outstanding Firm Orders automatically shall be cancelled.
(ii) Xxxxxx immediately shall cease all sales, marketing and distribution of the Generic Product and Salix promptly shall repurchase all saleable inventory of the Generic Product held by Xxxxxx as of the termination date at the Purchase Price paid by Xxxxxx for such Generic Product, and Xxxxxx shall deliver such Generic Product to Salix at Salix’s expense.
(iii) Salix shall reimburse Xxxxxx for any other rights reasonable and customary supplier penalties that are incurred by Xxxxxx for cancellation of either Party which may have accrued up to customer supply contracts that exist as of the date of the notice for such termination.
(j) Upon termination of this Agreement by Xxxxxx pursuant to Section 11.4(b):
(i) Xxxxxx immediately shall cease all sales, marketing and distribution of the Generic Product and Xxxxxx shall immediately destroy any inventory of Generic Product under its control, at its expense, and shall either, at Salix’s option, (A) allow a Salix representative to be present during such destruction or (B) provide a certificate of such destruction.
(ii) preclude either Party All then outstanding Firm Orders automatically shall be cancelled.
(iii) For a period of twelve (12) months from pursuing all rights and remedies it may have hereunder or at law or in equity with respect the effective date of such termination, Xxxxxx shall make monthly payments to any breach Salix, not later than forty-five (45) days after the end of this Agreement. Subject always each month during such twelve (12) month period, each of which payments shall be equal to other provisions [*]% of the Average Monthly Profits.
(k) Upon termination of this Agreement that provide by Salix pursuant to Section 11.4(b):
(i) Xxxxxx immediately shall cease all sales, marketing and distribution of the Generic Product and Salix promptly shall repurchase all saleable inventory of the Generic Product held by Xxxxxx as of the termination date at the Purchase Price paid by Xxxxxx for survival such Generic Product, and Xxxxxx shall deliver such Generic Product to Salix at Salix’s expense.
(ii) All then outstanding Firm Orders automatically shall be cancelled.
(iii) For a period of certain provisions following expiration or twelve (12) months from the effective date of such termination, Xxxxxx shall make monthly payments to Salix, not later than forty-five (45) days after the provisions end of Article 1 each month during such twelve (all)12) month period, Article 4 (due, but unpaid obligations), Article 5 (in relation each of which payments shall be equal to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 [*]% of the Average Monthly Profits. [*] Confidential treatment requested; certain information omitted and Article 13 shall survive expiration or termination of this Agreementfiled separately with the SEC.
Appears in 3 contracts
Samples: Supply and Distribution Agreement, Supply and Distribution Agreement (Salix Pharmaceuticals LTD), Supply and Distribution Agreement (Salix Pharmaceuticals LTD)
Effect of Expiration or Termination. (a) Upon expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 termination of this Agreement in its entirety for any reason, the following provisions shall be deemed survive: Sections 5.1, 5.4, 5.7, 6 (solely with respect to be paidamounts accrued prior to termination), 7, 8.4 (solely as it relates to ongoing rights and obligations of the parties following termination), and 9-up 12. Upon termination of this Agreement with respect to one or more Selected Antibodies for any reason, all rights and irrevocable;licenses granted hereunder with respect to such Selected Antibodies and related CAR Cells and CAR Products shall terminate, subject to the preceding sentence and each party shall properly destroy (and certify to the other party the destruction of) all such Selected Antibodies and related Confidential Information.
(iib) GW Pharma shallUpon termination of this Agreement by TeneoBio with respect to one or more Selected Antibodies for which Licensee has exercised the Commercial Option, at Otsuka’s electionany sublicense granted by Licensee under this Agreement with respect to such Selected Antibodies or related CAR Cells and CAR Products will survive as a direct license between TeneoBio and such Sublicensee on the same terms and conditions as those set forth in this Agreement, continue to supply Licensed Products the extent applicable to Otsuka on the rights granted by Licensee to such Sublicensee, provided that such Sublicensee is in compliance with the terms of the Manufacturing sublicense agreement and Supply Agreement for its term and Otsuka shall be entitled agrees to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 comply with all applicable terms of this Agreement shall continue for (including, without limitation, the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the financial terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated 6), and provided further that TeneoBio shall have no obligations under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, sublicense agreement that are greater than its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that obligations set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access toSections 2.5, as appropriate) the Otsuka Clinical Data 3 and all relevant Otsuka Know5-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same12 herein.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all Within […***…] days after the date of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 termination of this Agreement in its entirety, Licensee shall terminate pay to TeneoBio all amounts that have accrued and be are due hereunder on or prior to the date of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 termination. Upon termination of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreemententirety, each Receiving Party shall return to the other Party party or destroy, upon the written request of the other Party, any properly destroy (and certify destruction of) all Confidential Information of the other Party in its possessionparty, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, except that each Receiving Party may retain keep one copy of the other Partyparty’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunderarchival purposes only, subject to continuing confidentiality and non-use obligations.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.
Appears in 3 contracts
Samples: Commercial License Agreement (Poseida Therapeutics, Inc.), Commercial License Agreement (Poseida Therapeutics, Inc.), Commercial License Agreement (Poseida Therapeutics, Inc.)
Effect of Expiration or Termination. (a) Upon expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect relieve the Parties of any other rights of either Party which may have accrued up obligation accruing prior to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, and the provisions of Article 1 (all)Sections 1, Article 4 (due2, but unpaid obligations)5,7, Article 5 (in relation to activities occurring prior to expiration or termination)9.1, Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 9.6,10 and 12 and Article 13 shall survive the expiration or termination of this Agreement. Upon any termination of this Agreement, Licensor shall grant a direct license to any sublicense of Licensee hereunder having the same scope as such sublicense and on terms and conditions no less favorable to such Sublicensee than the terms and conditions of this Agreement, provided that such Sublicensee is not in default of any applicable obligations under this Agreement and agrees in writing to be bound by the terms and conditions of such direct license. Upon any termination of this Agreement, for a period of six (6) months thereafter, Licensee (and its Affiliates and Sublicensees) shall continue to be entitled to finish production of any Products which were in process at the time of termination, and Licensee (and its Affiliates and Sublicensees) shall be entitled to sell all Products which were in inventory or in process at the time of termination, so long as Licensee (and its Affiliates and Sublicensees) continues to make the reports and pay the scheduled royalties for said sales as set forth in this Agreement. ***** VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE COMMISSION.
Appears in 2 contracts
Samples: Exclusive License and Sublicense Agreement (VistaGen Therapeutics, Inc.), Exclusive License and Sublicense Agreement (VistaGen Therapeutics, Inc.)
Effect of Expiration or Termination. (a) Upon the expiration of this Agreement or the License Termtermination of this Agreement (or relevant portion thereof, all of the following will applyif termination is only as to a certain Product and/or country) as provided above:
(i) All 15.7.1. Expiration Where the Agreement expires in accordance with Section 15.1., then, in addition to any obligations expressly set forth elsewhere in this Agreement, the licenses and associated rights granted to Otsuka RIB-X by GW Pharma WAKUNAGA hereunder shall become fully paid-up, royalty-free, perpetual and irrevocable.
15.7.2. Breach by, Acquisition of or Insolvency of RIB-X or Termination by RIB-X Where termination is by WAKUNAGA pursuant to Section 2.1 of this Agreement shall be deemed to be paid15.2., 15.3. or 15.4., or by RIB-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights X pursuant to Section 2.215.5., then, in addition to any obligations expressly set forth elsewhere in this Agreement:
a) the licenses granted to RIB-X by WAKUNAGA hereunder shall terminate;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royaltyRIB-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates X and its sub-licensees covered by Sublicensees may, for a Valid Claim period of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject continue to sell existing inventory of Products provided that royalties on such Products are paid to WAKUNAGA as provided herein; Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the continuing Registrant’s application requesting confidential treatment pursuant to Rule 406 of this Agreement the Securities Act of 1933, as amended.
c) RIB-X shall pay any Milestone Payments due for events which are achieved prior to the effective date of termination;
d) RIB-X shall transfer to WAKUNAGA without any payment all governmental approvals and licenses for the Compound and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA including any Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicableApprovals, and the name and brief description of registration dossiers developed, acquired and/or used by RIB-X in the Licensed Product Territory during the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party and RIB-X shall return take all necessary procedures, including preparation of official documents, for such transfer at governmental authorities in the Territory by itself or its Sublicensees together with WAKUNAGA or WAKUNAGA’s designee. Such transfer shall be accompanied by documentation, data and information related to the other Party or destroyCompound and the Products that can be transferred by RIB-X; and
e) RIB-X shall grant WAKUNAGA a perpetual, upon non-royalty bearing, exclusive license, with the written request of the other Party, any and all Confidential Information of the other Party in its possession, exceptright to grant sublicenses, to all Rib-X Proprietary Information reasonably necessary for WAKUNAGA, alone or in conjunction with a Third Party to develop and commercialize the extent Compound and the Products.
15.7.3. Breach by or Insolvency of WAKUNAGA Where termination is by RIB-X pursuant to Section 15.3. or 15.4., then, in addition to any obligations expressly set forth elsewhere in this Agreement, the licenses granted by WAKUNAGA to RIB-X shall become fully-paid, royalty-free, perpetual and irrevocable; and RIB-X shall be entitled to retain copies of all Wakunaga Proprietary Information and Xxxxxx Proprietary Information as is necessary for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with RIB-X to exercise its obligations rights hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.
Appears in 2 contracts
Samples: License Agreement (Rib-X Pharmaceuticals, Inc.), License Agreement (Rib-X Pharmaceuticals, Inc.)
Effect of Expiration or Termination. (a) Upon Following expiration of the License Termterm of this Agreement with respect to a Product in a country in the Territory pursuant to Section 14.1(a), all BMS shall have the royalty-free, perpetual right to continue to manufacture, have manufactured, use and sell such Product in such country. Following expiration of the following will apply:term of this Agreement in its entirety pursuant to Section 14.1(b), BMS shall have the royalty-free, perpetual right to continue to manufacture, have manufactured, use and sell all Products in all countries in the Territory.
(b) Upon termination of this Agreement by BMS pursuant to Section 14.2: (i) All ICAgen shall promptly transfer to BMS copies of all data, reports, records and materials in ICAgen’s possession or control which relate to the Research Program, return to BMS all relevant records and materials in ICAgen’s possession or control containing Confidential Information of BMS to which ICAgen does not retain rights hereunder and furnish to BMS all Substances provided to ICAgen in connection with the Research Program; (ii) all licenses granted by BMS to ICAgen under Section 7 shall terminate; (iii) ownership of all INDs, NDAs and associated rights other regulatory filings made or filed for any Collaboration Compound or Product shall be transferred solely to BMS; and (iv) the exclusivity granted to Otsuka by GW Pharma BMS pursuant to Section 2.1 of this Agreement 4.8(a) shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on during the terms remainder of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled Exclusivity Period, if any. The licenses granted to exercise full manufacturing rights BMS by ICAgen pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures Sections 4.11 and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement 7 shall continue in full force and effect effect, subject to BMS’s obligations, including payment of royalties and milestones, as a royalty-free licenseprovided in Sections 5, 8 and otherwise on 9; provided, however, if at the same terms as set forth in Section2.3
(b) If time BMS terminates this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b)14.2, all a Collaboration Compound has not received PLP Approval as of the following will apply:effective date of such termination, then BMS shall be obligated to pay only [**]% of each of the milestones as provided in Sections 8.2 with respect to such Collaboration Compound.
(c) Upon termination of this Agreement by ICAgen pursuant to Section 14.2: (i) All licenses BMS shall promptly transfer to ICAgen copies of all data, reports, records and associated materials in BMS’s possession or control which relate to the Research Program, return to ICAgen all relevant records and materials in BMS’s possession or control containing Confidential Information of ICAgen to which BMS does not retain rights granted hereunder and furnish to Otsuka by GW Pharma pursuant ICAgen all Substances provided to Sections2.1 and 2.4 of this Agreement shall continue BMS in full force and effect as perpetual licenses, but otherwise on connection with the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
Research Program; (ii) GW Pharma shall, at Otsuka’s election, continue all licenses granted by ICAgen to supply Licensed Products to Otsuka on the terms of the Manufacturing BMS under Sections 4.11 and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
7 shall terminate; and (iii) In its sole discretion Otsuka ownership of all INDs, NDAs and other regulatory filings made or filed for any ICAgen Compound or Product shall be transferred solely to ICAgen. Thereafter, ICAgen shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and develop, make, have the right to ask GW Pharma to offer terms for the future supply of Licensed Products made, use, sell or just BDShave sold any ICAgen Compound or any ICAgen Compound Product. In such event, each such offer ICAgen Compound shall be deemed to be made a Grant-Back Compound and each such ICAgen Compound Product shall be deemed to be a Grant-Back Product, ICAgen shall pay milestones and royalties with respect thereto as provided in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Exhibit E, and ICAgen shall indemnify BMS as provided in Section 2.312.2(b). In the event that, following termination of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma ICAgen pursuant to Section 10.3(a)14.2, 10.3(b) BMS develops, makes, has made, uses, sells or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as has sold any BMS Compound that is a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it Collaboration Compound or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka willBMS Compound Product, within thirty (30) days of the Closing DateBMS shall pay milestones and royalties with respect thereto as provided in Sections 5.4, execute letters addressed to FDA 8 and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals9.
(d) If a portion of In the license granted by GW Pharma event either Party terminates this Agreement pursuant to Otsuka Section 14.2, such Party shall have the right to sublicense such Party’s rights under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii14.3(b) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.or
Appears in 2 contracts
Samples: Collaborative Research and License Agreement (Icagen Inc), Collaborative Research and License Agreement (Icagen Inc)
Effect of Expiration or Termination. (a) Upon Except as otherwise provided in Article 7, Article 13, or subsections (c) and (d) of this Section 15.4, expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 or termination of this Agreement shall be deemed result in the termination of all provisions hereof; PROVIDED, that Cytogen shall continue to be paid-up liable for all license fees and irrevocable;
Royalty (iiwith respect to all Agent that has then been sold by Cytogen or its Affiliates or Approved Sublicensees) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing payments that shall then have accrued and Supply Agreement for its term and Otsuka each Party shall be entitled to exercise full manufacturing rights pursuant to responsible for any amounts due under Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures 8.2 and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretionremaining unpaid.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party Cytogen shall return to AM (i) the other Party or destroyAgent Technology, upon (ii) the written request of the other PartyManufacturing Technology, any and all Confidential Information of the other Party if any, in its possession, exceptand (iii) Project Information not developed by Cytogen, to the extent and for so long or otherwise dispose of such Agent Technology, Manufacturing Technology or Project Information as such Party retains a license hereunder as provided instructed by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunderAM.
(fc) Expiration of the License Term or Upon termination of this Agreement by AM, Cytogen shall not (i) affect any other rights have the right to complete the sale of either Party which may have accrued up its inventory of the Agent in the Territory; PROVIDED, that Cytogen's obligations hereunder to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity comply with respect to any breach of this Agreement. Subject always to other provisions of this Agreement and the Supply Agreement in connection with such completion of sale shall remain in effect; and FURTHER PROVIDED, that provide if requested by AM, Cytogen shall negotiate with AM for survival the sale of certain provisions following expiration or termination, Cytogen's entire inventory of the provisions of Article 1 Agent to AM on terms to be negotiated by the Parties at such time.
(all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive d) Upon expiration or termination of this Agreement, neither Party shall have liability to the other Party for damages of any kind solely as a result of the fact of such expiration or termination, whether on account of the loss by Cytogen of present or prospective sales, investments or goodwill arising solely from statutes that relate to termination of distributors or licensees, and each Party hereby waives any rights which may be granted to it by such statutes.
Appears in 2 contracts
Samples: Annual Report, License and Marketing Agreement (Advanced Magnetics Inc)
Effect of Expiration or Termination. (a) Upon Following expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 term of this Agreement shall be deemed under Section 10.1 with respect to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified a Product in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for Field in the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka Territory JCR shall have the royalty-free, perpetual right to terminate manufacture, have manufactured, use and sell such Product in the Manufacture and Supply Agreement according to its terms including as to notice period and have Field in the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretionTerritory.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 Upon termination of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent 10.2, 10.4 or 10.7 (***%) other than as a result of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. breach of this Agreement by OSIRIS), JCR shall continue in full force and effect on the terms set forth in Section 2.3and as set out belowpromptly: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-transfer free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shallcharge, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all OSIRIS or such other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma Person as OSIRIS shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Partydesignate, any and all Confidential Information rights that it may have under any government registrations or authorizations, including Product Registrations, with respect to Product in the Field, and shall immediately cancel any such registrations or authorizations, including Product Registrations, with respect thereto as may not be transferable; (ii) provide to OSIRIS all data and other information in JCR’s, or its Affiliates’ or Sublicensees’ possession or control relating to such Product Registrations; and (iii) discontinue all distribution of Product and the use of the other Party OSIRIS Patents and OSIRIS Technology and JCR Special Technology in its possessionconnection therewith. All rights of JCR under the licenses for such Product granted hereunder shall revert to OSIRIS. The rights and licenses granted to JCR shall terminate with respect to Product; (iv) grant OSIRIS a non-exclusive, exceptroyalty-bearing license at a reasonable royalty under and to JCR Special Technology and JCR Patents to make, have made, use, sell, offer to sell and import Products in the Field for use in the Territory, including a right to sublicense a Third Party(ies) in conjunction with a license to OSIRIS Technology and provide to OSIRIS such technology that is licensed to OSIRIS under this Section 10.3(b) to the extent and for so long as such Party retains a license hereunder as that it has not been previously provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunderto OSIRIS.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.
Appears in 2 contracts
Samples: License Agreement (Mesoblast LTD), License Agreement (Osiris Therapeutics, Inc.)
Effect of Expiration or Termination. (a) Upon expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) 10.5.1 Expiration of the License Term or termination of this Agreement shall not relieve the parties of any obligation accruing prior to such expiration or termination (i) affect any other rights including all accrued payment obligations), and the provisions of either Party which may have accrued up Sections 2.6, 2.7, 3.3.1 (to the date extent of such any continuing obligations under the Opus In-Licenses), 3.
3.6, 5.1 ( for purposes of Juno filing a final royalty report for Net Sales through the termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach expiration of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due5.2, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.48, 9.5, 10.6 to 10.8 inclusive10, Article 11, Article 12 11 and Article 13 shall survive the expiration or termination of this Agreement.
10.5.2 If this Agreement is terminated for any reason, any Third Party sublicensee of Juno hereunder who is in full compliance with the terms and conditions of the sublicense shall be entitled to become a direct licensee of Opus under the terms of this Agreement with respect to the rights sublicensed by Juno to the sublicensee (including the territory and products); provided that, as a condition of receiving such direct license from Opus, (a) the sublicensee must not be in material breach of its sublicense, (b) the sublicensee did not contribute by any act or omission to a breach of this Agreement by Juno that, if applicable, led to the termination of this Agreement, and (c) the sublicensee must agree to assume all of Juno’s future obligations (i.e., obligations after becoming such direct licensee) under this Agreement with respect to the rights sublicensed by Juno to the sublicensee, to the extent relating to the activities of the sublicensee. [***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
10.5.3 Upon termination of this Agreement for any reason, except as provided in this Article 10, all rights and licenses granted to Juno (including all licenses under Section 3.1) will terminate.
10.5.4 Unless this Agreement is terminated by Juno pursuant to Section 10.3 or by Opus pursuant to Section 10.4, Juno shall have the right to sell or otherwise dispose of all Products in the process of manufacture, testing, in use or in stock for a period of [***] from such termination; provided that Juno shall remain obligated to make payment of royalties to Opus for such Products in accordance with Article 4.
10.5.5 Upon termination of this Agreement by Juno pursuant to Section 10.3 or by Opus pursuant to Section 10.4:
(a) Juno shall [***], transfer to Opus all Product and all related reagents, intermediates, or other materials, including vector or other transduction materials, it has on hand related to the Product and any ongoing or contemplated clinical trials. Juno shall also manufacture the Product for Opus in a manner materially consistent with Juno’s efforts to manufacture other engineered T-cells for its own purposes pursuant to terms and conditions customary in pharmaceutical manufacturing agreements, including IP warranties and indemnification obligations. Opus shall reimburse Juno at a transfer price equal to [***] of Juno’s fully burdened cost to manufacture the Product (as determined in accordance with generally accepted accounting principles in the United States).
Appears in 2 contracts
Samples: Exclusive License Agreement, Exclusive License Agreement
Effect of Expiration or Termination. (a) Upon Following expiration of the License Termterm of this Agreement: [*] = Certain confidential information contained in this document, all marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the following will apply:Securities Act of 1933, as amended.
(i) All licenses R-Pharm, to the extent required by law, shall have a non-exclusive, royalty-free, perpetual right to continue to make, have made, use, market, distribute, sell, export within the Territory and/or import all Products in all countries in the Territory, and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be the non-exclusive, perpetual and paid-up and irrevocableright to use the Licensed Technology in connection therewith;
(ii) GW Pharma shall, at Otsuka’s election, Scynexis shall have: (A) the fully-paid non-exclusive right to continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royaltycross-free license, reference and otherwise on the same terms exercise its rights as set forth in Section2.3Section 4 under the Registrations and other regulatory filings for all Products in all countries in the Territory; and (B) the fully-paid, non-exclusive, perpetual right to continue to use patents or know-how that embody or relate to the Inventions described in Section 5.6 solely for the purposes set forth in Section 5.6.
(b) If this Agreement is terminated with respect to a portion of the Territory (the “Subject Portion”) by Otsuka Scynexis pursuant to Section 10.3(a) Sections 4.8, 5.3, 12.2 or 10.3(b14.5(d), all of the following will apply:
(i) All licenses and associated rights granted in addition to Otsuka by GW Pharma pursuant any other remedies available to Sections2.1 and 2.4 of this Agreement shall continue Scynexis at law or in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out belowequity: (i) where R-Pharm shall promptly transfer to Scynexis copies of all data, reports, records and materials in R-Pharm’s possession or control that relate, whether exclusively or non-exclusively, to the Agreement Territory Development Plan and return to Scynexis all relevant records and materials in R-Pharm’s possession or control that relate exclusively to the Subject Portion and contain Confidential Information of Scynexis (provided that R-Pharm may keep one hard (non-electronic) copy of such [*] = Certain confidential information contained in this document, marked by brackets, has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable Securities and Exchange Commission pursuant to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate Rule 406 of (or complete access tothe Securities Act of 1933, as appropriateamended. Confidential Information of Scynexis for archival purposes only); (ii) the Otsuka Clinical Data and all relevant Otsuka Knowlicenses granted by Scynexis to R-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, Pharm hereunder shall terminate with respect to the extent legally practicableSubject Portion; (iii) R-Pharm shall transfer to Scynexis, assign or shall cause its designee(s) under Section 4.4(b) to Otsuka its righttransfer to Scynexis, title ownership of all INDs, Registration Applications, Registrations and interest in and to each IND and all other regulatory filings made or filed for the Product in the Subject Portion; and (iv) R-Pharm shall transfer to Scynexis all rights to use the Trademark with respect to any Licensed the Product in all countries throughout the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the sameSubject Portion.
(c) If this Agreement is terminated in its entirety by GW Pharma Scynexis pursuant to Section 10.3(a), 10.3(b4.8, 5.3, 12.2 or 14.5(d) by reason of a breach by R-Pharm, in addition to any other remedies available to Scynexis at law or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
in equity: (i) The licenses R-Pharm shall promptly transfer to Scynexis copies of all data, reports, records and associated rights granted materials in Scynexis’ possession or control that relate to the Territory Development Plan and return to Scynexis all relevant records and materials in R-Pharm’s possession or control containing Confidential Information of [*] = Certain confidential information contained in this document, marked by GW Pharma brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Otsuka under Sections 2.1 and 2.4 Rule 406 of this Agreement shall terminate and be the Securities Act of no further force or effect.
1933, as amended. Scynexis (provided that R-Pharm may keep one copy of such Confidential Information of Scynexis for archival purposes only); (ii) The license all licenses granted by Otsuka Scynexis to GW Pharma under R-Pharm hereunder shall terminate; (iii) R-Pharm shall transfer to Scynexis ownership of all INDs, Registration Applications, Registrations and other regulatory filings made or filed for the Product; and (iv) R-Pharm shall transfer to Scynexis all rights to use the Trademark with respect to the Product in all countries throughout the Territory. Furthermore, Scynexis shall have a fully-paid, non-exclusive, perpetual right to continue to use patents or know-how that embody or relate to the Inventions described in Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on 5.6 solely for the same terms as purposes set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it5.6.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.
Appears in 2 contracts
Samples: Development, License and Supply Agreement, Development, License and Supply Agreement (Scynexis Inc)
Effect of Expiration or Termination. (a) Upon Following expiration of the License Termterm of this Agreement with respect to a Product in a country in the applicable Territory pursuant to Section 13.1(a), all the licensee Party under this Agreement shall have the royalty-free, perpetual right to continue to manufacture, have manufactured, use and sell such Product in such country. Following expiration of the following will apply:term of this Agreement in its entirety pursuant to Section 13.1(b), the licensee Party shall have the royalty-free, perpetual right to continue to manufacture, have manufactured, use and sell all Products previously licensed by it in all countries in the applicable Territory.
(b) Upon termination of this Agreement by YAMANOUCHI pursuant to Section 13.2: (i) All ICAgen shall promptly transfer to YAMANOUCHI copies of all data, reports, records and materials in ICAgen’s possession or control which relate to the Research Program, return to YAMANOUCHI all relevant records and materials in ICAgen’s possession or control containing Confidential Information of YAMANOUCHI to which ICAgen does not retain rights hereunder and furnish to YAMANOUCHI all Substances provided to ICAgen by YAMANOUCHI in connection with the Research Program; (ii) all licenses and associated rights granted by YAMANOUCHI to Otsuka by GW Pharma pursuant to ICAgen under Section 2.1 of this Agreement 5 shall terminate; (iii) ICAgen shall be deemed to be paid-up have given an ICAgen Abandonment Notice as to all Clinical Compounds and irrevocable;
Products based thereon then being developed or commercialized by ICAgen; and (iiiv) GW Pharma shall, at Otsuka’s election, continue the exclusivity granted to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights YAMANOUCHI pursuant to Section 2.2;
(iii) Otsuka 2.8 shall be entitled to require continue during the transfer remainder of manufacturing technologythe Exclusivity Period, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All if any. The licenses and associated rights granted to GW Pharma YAMANOUCHI by Otsuka ICAgen pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement 5 shall continue in full force and effect effect, subject to YAMANOUCHI’s obligations under this Agreement, including payment of royalties and milestones, as a royalty-free licenseprovided in Sections 5, 6, and otherwise on the same terms as set forth in Section2.37.
(bc) If Upon termination of this Agreement is terminated by Otsuka ICAgen pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
13.2: (i) All YAMANOUCHI shall promptly transfer to ICAgen copies of all data, reports, records and materials in YAMANOUCHI’s possession or control which relate to the Research Program, return to ICAgen all relevant records and materials in YAMANOUCHI’s possession or control containing Confidential Information of ICAgen to which YAMANOUCHI does not retain rights hereunder and furnish to ICAgen all Substances provided to YAMANOUCHI by ICAgen in connection with the Research Program; (ii) all licenses granted by ICAgen to YAMANOUCHI under Section 5 shall terminate; (iii) YAMANOUCHI shall be deemed to have given a YAMANOUCHI Abandonment Notice as to all Clinical Compounds and associated rights Products based thereon then being developed or commercialized by YAMANOUCHI; and (iv) the exclusivity granted to Otsuka by GW Pharma YAMANOUCHI pursuant to Sections2.1 and 2.4 of this Agreement Section 2.8 shall terminate. The licenses granted to ICAgen by YAMANOUCHI pursuant to Section 5 shall continue in full force and effect as perpetual licenseseffect, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of subject to ICAgen’s obligations under this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case including payment of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access toroyalties, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Propertyprovided in Sections 5, 6, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals7.
(d) If a portion Upon termination of this Agreement by YAMANOUCHI pursuant to Section 13.3, all rights to YAMANOUCHI Compounds shall revert to YAMANOUCHI and all rights to ICAgen Compounds shall revert to ICAgen, unless and to the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out extent otherwise provided in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product2.9 above.
(e) Within thirty (30) days following In the expiration event of the License Term or termination of this Agreementany license rights granted to either Party as provided in Section 13.4(b) or (c), each Party shall return to the other Party or destroy, upon shall recognize the written request of the other sublicenses previously granted hereunder to such Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 ’s Sublicensees; provided, however, that each the other Party may retain one copy shall not assume, and shall not be responsible to any such Sublicensee for, any representations, warranties or obligations of the other Party’s Confidential Information for Party that granted the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect sublicense to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this AgreementSublicensee.
Appears in 2 contracts
Samples: Collaborative Research and License Agreement (Icagen Inc), Collaborative Research and License Agreement (Icagen Inc)
Effect of Expiration or Termination. (a) Upon Following the expiration of the License Term, all term of the following will apply:
(i) All licenses and associated rights granted this Agreement with respect to Otsuka by GW Pharma a Product in any country in a Territory pursuant to Section 2.1 of this Agreement 12.1(a) or 12.1(b), Genentech shall be deemed have a royalty-free, paid-up, perpetual, irrevocable and sublicenseable right and license, exclusive for [CONFIDENTIAL TREATMENT REQUESTED] and nonexclusive thereafter, to be continue to develop, make, have made, use, market, sell, have sold, offer to sell, import, distribute and otherwise exploit such Product in such country, and the exclusive, perpetual, irrevocable, sublicenseable, royalty-free and paid-up right and irrevocable;
(ii) GW Pharma shalllicense to use the Licensed Technology in connection therewith. To that end, at Otsuka’s election, Genentech may continue to supply Licensed Products hold and use all data, reports, records, information and materials that relate to Otsuka on or are prepared in the terms course of the Manufacturing Development Program, and Supply Agreement may hold all INDs, Registration Applications, Registrations and other regulatory filings made or filed by Genentech for its term and Otsuka shall be entitled to exercise full manufacturing rights such Products pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technologythis Agreement, protocols, standard operating procedures and the like as specified may in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights continue any sublicense granted by Otsuka to GW Pharma pursuant to Section 2.3 of Genentech under this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3Agreement.
(b) If Following expiration of the term of this Agreement is terminated by Otsuka in its entirety pursuant to Section 10.3(a) or 10.3(b12.1(c), Genentech shall have a royalty-free, paid-up, perpetual, irrevocable and sublicenseable right and license, exclusive for [CONFIDENTIAL TREATMENT REQUESTED] and nonexclusive thereafter, to continue to develop, make, have made, use, market, sell, have sold, offer to sell, import, distribute and otherwise exploit all Products in the Territory, and the exclusive, perpetual, irrevocable, sublicenseable, royalty-free and paid-up right and license to use the Licensed Technology in connection therewith. To that end, Genentech may continue to hold and use all data, reports, records and materials that relate to or are prepared in the course of the following will apply:
(i) All licenses Development Program, and associated rights granted to Otsuka may hold all INDs, Registration Applications, Registrations and other regulatory filings made or filed by GW Pharma Genentech for all Products, pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only may in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license continue any sublicense granted by Otsuka to GW Pharma Genentech under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the sameAgreement.
(c) If this Agreement is terminated by GW Pharma Inspire with respect to a particular Product pursuant to Section 10.3(a)12.2 by reason of a material breach or default by Genentech, 10.3(b) or 10.4 or terminated by Otsuka Genentech with respect to a particular Product pursuant to Section 10.5 all of 12.3, in addition to any other remedies available to the following will apply:
Parties at law or in equity: (i) The licenses at Genentech's expense, Genentech shall promptly transfer to Inspire copies of all relevant data, reports, records and associated rights granted by GW Pharma materials in Genentech's possession or control that relate to Otsuka under Sections 2.1 the Product and 2.4 return to Inspire all relevant records and materials in Genentech's possession or control containing Confidential Information of this Agreement shall terminate and be Inspire with respect to such Product (provided that Genentech may keep one (1) copy of no further force or effect.
such Confidential Information of Inspire for archival purposes only); (ii) The Genentech shall, upon Inspire's request and at Genentech's expense, provide Inspire with all information necessary or desirable to cross-reference and/or assume responsibility for any of Genentech's INDs, Registrations Applications, Registrations and other regulatory filings in the Fields with respect to such Product; (iii) the license granted by Otsuka Inspire to GW Pharma Genentech under Section 2.3 of 6.1 shall terminate; and (iv) all sublicenses granted by Genentech under this Agreement shall continue in full force and effect as a worldwide royalty-free licensein accordance with the terms and conditions of the respective sublicense agreements, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled Genentech will assign such sublicense agreements to a complete duplicate of (or complete access toInspire; provided, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereofhowever, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of that this Section 10.7(c)12.4(c) shall not apply to any Confidential Information, Otsuka licenses and its sublicensees shall have the right and license in the Field sublicenses relating to sell, offer any Products for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following which there has not been a termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If this Agreement is terminated by Inspire pursuant to Section 12.2 by reason of a portion material breach or default by Genentech, or terminated by Genentech pursuant to Section 12.3, in addition to any other remedies available to the Parties at law or in equity: (i) Genentech shall promptly transfer to Inspire copies of all data, reports, records and materials in Genentech's possession or control that relate to the Development Program and return to Inspire all relevant records and materials in Genentech's possession or control containing Confidential Information of Inspire (provided that Genentech may keep one (1) copy of such Confidential Information of Inspire for archival purposes only); (ii) Genentech shall, upon Inspire's request and at Genentech's expense, provide Inspire with all information necessary or desirable to cross-reference and/or assume responsibility for any of Genentech's INDs, Registrations Applications, Registrations and other regulatory filings in the Fields with respect to all Products; (iii) the license granted by GW Pharma Inspire to Otsuka Genentech under Section 2.1 is terminated 6.1 shall terminate; and (iv) all sublicenses granted by OtsukaGenentech under this Agreement shall continue in full force and effect in accordance with the terms and conditions of the respective sublicense agreements, in relation and Genentech shall assign such sublicense agreements to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed ProductInspire.
(e) Within thirty If this Agreement is terminated by Genentech pursuant to Section 12.2 by reason of a material breach or default by Inspire, in addition to any other remedies available to Genentech at law or in equity: (30i) days following the license granted to Inspire by Genentech under Section 6.2 shall terminate; (ii) Genentech shall have an exclusive, royalty-free, paid-up, perpetual, irrevocable and sublicenseable right to continue to develop, make, have made, use, market, sell, have sold, offer to sell, import, distribute and otherwise exploit any Products in the Territory, and the exclusive, perpetual, irrevocable, sublicenseable, royalty-free and paid-up right and license to use the Licensed Technology in connection therewith. To that end, Genentech may continue to hold and use all data, reports, records, information and materials that relate to or are prepared in the course of the Development Program, and may hold all INDs, Registration Applications, Registrations and other regulatory filings made or filed by Genentech for the Products, pursuant to this Agreement, and may in its sole discretion continue any sublicenses granted by Genentech under this Agreement.
(f) At the expiration of the License Term or any termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request all of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its Genentech's payment obligations hereunder.
(f) Expiration of the License Term or termination of under this Agreement shall not (i) affect any other rights terminate as of either Party which may have accrued up to the effective date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation except for payments to activities occurring Inspire for any royalties or Operating Profit or Loss percentage under Section 7 that accrued prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive the effective date of such expiration or termination of and are due and payable by Genentech to Inspire pursuant to this Agreement.
Appears in 1 contract
Samples: Development, License and Supply Agreement (Inspire Pharmaceuticals Inc)
Effect of Expiration or Termination. (a) Upon The expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 or earlier termination of this Agreement shall be deemed without prejudice to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms any rights or obligations of the Manufacturing Parties that may have accrued prior to such termination. Those provisions that by their terms or intent are required to survive the expiration or earlier termination of the Agreement in order to give effect to the intent of the Parties shall so survive. Without limiting the foregoing, the provisions of Sections 4.5, 6.3 and Supply Agreement for its term 8.3 and Otsuka ARTICLE 5, ARTICLE 7, ARTICLE 9 and ARTICLE 10 shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require survive the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 expiration or termination of this Agreement shall and continue for thereafter in accordance with and to the term extent of the Manufacturing and Supply Agreement so long their terms. Except as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDSotherwise expressly provided herein, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 termination of this Agreement in accordance with the provisions hereof shall continue not limit remedies that may otherwise be available at law or in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3equity.
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) Upon expiration or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder earlier termination of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be dueeach Party, but only in at the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments request of the Licensed Intellectual Propertyother, shall return all data, files, records and same, if not already other materials in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsukapossession or Control containing or comprising the other Party’s election, continue to supply Licensed Products to Otsuka on Confidential Information except that the terms legal department of the Manufacturing and Supply Agreement such Party may retain one copy solely for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3archival purposes. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If Upon any termination of this Agreement is terminated by GW Pharma Intercept pursuant to Section 10.3(a), 10.3(b8.2(a) or 10.4 or by Otsuka PharmaZell pursuant to Section 10.5 all of the following will apply:
8.2(c), (i) The licenses PharmaZell shall return to Intercept all Intercept Materials, (ii) Intercept shall purchase from PharmaZell the amount of Supplied Material that is subject to Work Orders outstanding at the time of such termination, (iii) Intercept shall reimburse PharmaZell for work in process and associated rights granted Materials that PharmaZell has purchased for the purpose of supplying Supplied Material to Intercept in accordance with the delivered Work Orders, and (iv) Intercept shall pay PharmaZell’s direct cost for any such work in process in accordance with the Work Orders and PharmaZell’s purchase price from its suppliers for any such Materials ordered for such Work Orders that have a minimum of [**] shelf life and have been stored and controlled by GW Pharma PharmaZell per the Quality Agreement; provided, however that PharmaZell shall use reasonable best efforts to Otsuka under Sections 2.1 and 2.4 return such Materials to suppliers or use such Materials in the manufacture of product for third parties. In the event of termination of this Agreement by Intercept pursuant to Section 8.2(b), 8.2(c) or 8.2(d), at the request of Intercept, PharmaZell shall terminate fulfill all outstanding Work Orders for Supplied Materials prior to the effective date of such termination and be to the extent not used to fulfill Work Orders at Intercept’s request, PharmaZell shall return to Intercept all Intercept Materials.
(d) Except as and to the extent contemplated by Section 8.3(c), upon expiration of no further force this Agreement or effectany earlier termination of this Agreement, PharmaZell immediately shall cease all Manufacturing of Supplied Materials pursuant to this Agreement.
(e) Following expiration or termination of this Agreement, PharmaZell shall (i) provide Intercept with such reasonable cooperation and support with respect to regulatory matters as Intercept may require in order to dispose of previously purchased API, (ii) The license granted by Otsuka grant to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as Intercept a worldwide perpetual, irrevocable, non-exclusive royalty-free licenselicense (with the right to grant sublicenses) under know-how, patents and other intellectual property rights owned, licensed or otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of controlled by PharmaZell (or complete access to, any of its Affiliates) as appropriate) may be necessary or useful for the Otsuka Clinical Data purpose of making and all relevant Otsuka Know-How having made the API and all embodiments thereof, API Precursor and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, provide to Intercept copies of the provisions physical embodiment of Article 1 (all)those processes, Article 4 (dueprotocols, but unpaid obligations)procedures, Article 5 (methods, tests and other know-how, relating to the Manufacturing of the API and API Precursor. In addition, PharmaZell shall provide reasonable assistance to Intercept and its Affiliates with respect to assisting Intercept and its Affiliates in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination obtaining all necessary regulatory approvals and/or modifying existing Regulatory Approvals for the Manufacture of this Agreement.the API.
Appears in 1 contract
Samples: Manufacturing Agreement (Intercept Pharmaceuticals, Inc.)
Effect of Expiration or Termination. Notwithstanding any other rights or obligations a Party or its Affiliates may have under this Agreement or under Applicable Law, except as otherwise provided herein (aincluding Section 6.1(f) Upon expiration of the License Termwith respect to expiration), all of the following will apply:
upon termination (ibut not expiration) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of a termination under by Biodexa pursuant to Section 10.3(a12.2(b) with respect to one or more countries, such provisions shall be due in amounts reduced only apply to such particular country being terminated and shall have no application or effect on any of the other countries not being terminated), (i) all rights and licenses granted by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled Melior to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property Biodexa and its Affiliates and all embodiments rights and licenses granted by Biodexa to Melior and its Affiliates hereunder shall terminate and revert to the Party granting such rights and all of the Licensed Intellectual PropertyParties’ obligations under this Agreement shall, except as specifically provided in Section 12.3 or this Section 12.4, cease, terminate and samebe of no further force and effect from and after the effective date of expiration or termination, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shallfollowing mutual agreement by Biodexa and Mxxxxx regarding a customary reverse royalty payment obligation, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka Biodexa shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and transfer all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect Development Data to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuingMelior, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision royalties that have accrued and would otherwise be payable hereunder shall be prorated through the effective date of this Section 10.7(c), Otsuka expiration or termination. The Parties and its sublicensees their Affiliates shall have the right and license cooperate in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all informing relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days Governmental Authorities of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form cessation of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, their activities in relation to a particular the Licensed Product then Products. In addition, the provisions set out in Section 10.7(c)(i)Parties shall, 10.7(c)(ii)and shall ensure that their respective Affiliates, 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall promptly return to the other Party Parties or destroy, upon the destroy (subject to written request certification of the other Party, any and latter) all Confidential Information of the other Party in its possessionwritten, exceptelectronic or material form, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain all copies thereof (except one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide be kept for survival of certain provisions following expiration or termination, the provisions of Article 1 (allrecord-keeping purposes only), Article 4 (due, but unpaid obligations), Article 5 (in relation belonging to activities occurring prior such other Parties. Biodexa covenants and agrees that it will fund to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 closure any active and Article 13 shall survive expiration or termination of this Agreement.ongoing Clinical Study involving previously dosed patients with the Licensed Product,
Appears in 1 contract
Effect of Expiration or Termination. (a) Upon expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement for any reason:
11.6.1 The Parties shall not (i) affect be relieved of any other rights of either Party which may have accrued up obligation accruing prior to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, and the provisions of Article 1 (all)Articles 1, Article 4 (due7, but unpaid obligations)8, Article 5 (in relation to activities occurring prior to expiration or termination)9, Article 6 (Confidentiality),Sections 9.410, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 Section 11.6 shall survive the expiration or termination of this Agreement.
11.6.2 All licenses and other rights granted by CaspianTern to Hansoh under this Agreement shall terminate. The licenses granted to Hansoh in Section 3.1 shall terminate solely with respect to the Licensed Compound(s), Licensed Product(s) and Region(s) in which the termination becomes effective; provided, however, that Hansoh and other Selling Parties, as applicable, shall be permitted to distribute and sell all Licensed Products that were in inventory or in production on an effective termination date for a period of [***] following the effective termination date, in accordance with the terms of this Agreement. In the event of a Termination for Breach by CaspianTern without cure, all licenses and rights granted by CaspianTern to Hansoh under this Agreement shall survive with all Milestone Payments and Royalty Payments obligations payable by Hansoh to CaspianTern reduced by [***]. In the event that this Agreement is terminated in its entirety, CaspianTern shall have the right, but not the obligation, to purchase any and all of the inventory of Licensed Products held by Hansoh or its Affiliates as of the date of termination, at a price agreed by the Parties.
11.6.3 Termination of this Agreement shall be construed as a termination of all Sublicenses hereunder.
11.6.4 CaspianTern shall have the right (including a reversion of all rights previously licensed to Hansoh hereunder for which the relevant licenses have terminated) to Exploit Licensed Products itself or with or through an Affiliate or one or more Third Parties in the Field in the Territory, and shall have the right, without obligation to Hansoh, to take any such actions in connection with such activities as CaspianTern (or its designee), at its discretion, deems appropriate. [***] = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED]
11.6.5 Wind-Down. Hansoh will (i) responsibly wind-down, in accordance with accepted pharmaceutical industry norms and ethical practices, any on-going clinical trials for which it has responsibility hereunder in which patient dosing has commenced or, (ii) at CaspianTern’s reasonable request, (A) transfer to CaspianTern or its designee such clinical trial to the extent permitted under Applicable Laws and accepted pharmaceutical industry norms and ethical practices, or (B) if reasonably practicable and not adverse to patient safety, complete such clinical trials and CaspianTern shall reimburse Hansoh its reasonable, out-of-pocket costs associated therewith.
Appears in 1 contract
Samples: Exclusive Option and License Agreement (Terns Pharmaceuticals, Inc.)
Effect of Expiration or Termination. (a) Upon expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) 10.5.1 Expiration of the License Term or termination of this Agreement shall not relieve the parties of any obligation accruing prior to such expiration or termination (i) affect any other rights including all accrued payment obligations), and the provisions of either Party which may have accrued up Sections 2.6, 2.7, 3.3.1 (to the date extent of such any continuing obligations under the Opus In-Licenses), 3.3.6, 5.1 (for purposes of Juno filing a final royalty report for Net Sales through the termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach expiration of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due5.2, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.48, 9.5, 10.6 to 10.8 inclusive10, Article 11, Article 12 11 and Article 13 shall survive the expiration or termination of this Agreement.
10.5.2 If this Agreement is terminated for any reason, any Third Party sublicensee of Juno hereunder who is in full compliance with the terms and conditions of the sublicense shall be entitled to become a direct licensee of Opus under the terms of this Agreement with respect to the rights sublicensed by Juno to the sublicensee (including the territory and products); provided that, as a condition of receiving such direct license from Opus, (a) the sublicensee must not be in material breach of its sublicense, (b) the sublicensee did not contribute by any act or omission to a breach of this Agreement by Juno that, if applicable, led to the termination of this Agreement, and (c) the sublicensee must agree to assume all of Juno’s future obligations (i.e., obligations after becoming such direct licensee) under this Agreement with respect to the rights sublicensed by Juno to the sublicensee, to the extent relating to the activities of the sublicensee.
10.5.3 Upon termination of this Agreement for any reason, except as provided in this Article 10, all rights and licenses granted to Juno (including all licenses under Section 3.1) will terminate.
10.5.4 Unless this Agreement is terminated by Juno pursuant to Section 10.3 or by Opus pursuant to Section 10.4, Juno shall have the right to sell or otherwise dispose of all Products in the process of manufacture, testing, in use or in stock for a period of [***] from such termination; provided that Juno shall remain obligated to make payment of royalties to Opus for such Products in accordance with Article 4.
10.5.5 Upon termination of this Agreement by Juno pursuant to Section 10.3 or by Opus pursuant to Section 10.4:
(a) Juno shall [***], transfer to Opus all Product and all related reagents, intermediates, or other materials, including vector or other transduction materials, it has on hand related to the Product and any ongoing or contemplated clinical trials. Juno shall also manufacture the Product for Opus in a manner materially consistent with Juno’s efforts to manufacture other engineered T-cells for its own purposes pursuant to terms and conditions customary in pharmaceutical manufacturing agreements, including IP warranties and indemnification obligations. Opus shall reimburse Juno at a transfer price equal to [***] of Juno’s fully burdened cost to manufacture the Product (as determined in accordance with generally accepted accounting principles in the United States).
Appears in 1 contract
Samples: Exclusive License Agreement (Juno Therapeutics, Inc.)
Effect of Expiration or Termination. (a) Upon expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive After expiration or termination of this Licensing Agreement for any reason:
(a) All rights granted to the Licensee shall forthwith revert to UCANN and all of the Products, Packaging, Concentrate or Prana IP shall remain the sole property of UCANN. Licensee shall provide UCANN with contact information for and authorization to UCANN to work with any vendors used by Licensee in any way related to the Products, Packaging, Concentrate, or Prana IP;
(b) Licensee shall immediately discontinue the production, manufacture, advertising, use, distribution and sale of all Products, Packaging and marketing materials, Trademarks, and all similar marks, subject to any right of Sell-Off Period pursuant to paragraph 12.2 below, or if otherwise authorized in writing by UCANN;
(c) Payments shall be payable in accordance with Section 10 above and shall immediately become due and payable to UCANN;
(d) Licensee shall deliver to UCANN within 30 business days a statement indicating the number and description of the Products in stock or in the process of manufacture as at such expiration of the Term or earlier termination of this Agreement. UCANN may, upon reasonable prior notice, require the Licensee to conduct a physical inventory in the presence of the UCANN’s duly authorized representative in order to ascertain or verify such statement;
(e) Licensee shall deliver to UCANN all creations, designs, materials and intellectual property created or licensed by Licensee pursuant to paragraph 2.1 above or provided to it by UCANN;
(f) All warranties and indemnification obligations of the parties and all provisions which expressly or by implication are intended to apply after expiration or termination of this agreement shall survive and continue to apply;
(g) Any termination hereunder will be without prejudice to any of UCANN’s rights or remedies.
Appears in 1 contract
Samples: Supply, Distribution, and Licensing Agreement (United Cannabis Corp)
Effect of Expiration or Termination. As of the Closing Date:
(a) Upon expiration The first (1st) sentence of Section 12.3 of the License Term, all of Agreement shall be deleted in its entirety and replaced with the following will apply:
following: “So long as this Agreement: (i) All licenses and associated rights granted has expired pursuant to Otsuka its terms (e.g., it was not terminated by GW Pharma Licensor for any reason pursuant to the terms of this Agreement, other than pursuant to Section 2.1 3.3(g) of the Agreement), (ii) was terminated by Licensee pursuant to the express terms of Section 3.3 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms provided that notice of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights termination sent pursuant to Section 2.2;
3.3 is not after and/or in response to a breach notice sent by Licensor to Licensee), or (iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma was terminated by Otsuka Licensor pursuant to Section 2.3 3.3(g) of the Agreement for Licensee’s failure to meet Minimum Net Sales as specified therein), then: Licensee may complete (but only in accordance with the terms and conditions of this Agreement shall continue Agreement) production of Approved Licensed Merchandise which is in process, or for the term which written orders have been received from customers, all as of the Manufacturing and Supply date of expiration of this Agreement. In the event this Agreement so long as the Manufacturing and Supply Agreement is not is: (A) terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms Licensor for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma any reason other than pursuant to Section 2.3 3.3(g) (for Licensee’s failure to meet Minimum Net Sales as specified therein), or (B) terminated by Licensee after and/or in response to a breach notice sent by Licensor to Licensee, then: Licensee shall immediately cease production of Approved Licensed Merchandise which is in process, or for which written orders have been received from customers, all as of the date of termination of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3Agreement.”
(b) If this Agreement is terminated by Otsuka pursuant to The first (1st) sentence of Section 10.3(a) or 10.3(b), all 12.4 of the following will apply:
Agreement shall be deleted in its entirety and replaced with the following: “So long as this Agreement: (i) All licenses and associated rights granted to Otsuka by GW Pharma has expired pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licensesits terms (e.g., but otherwise on it was not terminated by Licensor for any reason pursuant to the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due other than pursuant to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%3.3(g) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access tothe Agreement), as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue was terminated by Licensee pursuant to supply Licensed Products to Otsuka on the express terms of the Manufacturing and Supply Section 3.3 of this Agreement for the longer (provided that notice of its term termination sent pursuant to Section 3.3 is not after and/or in response to a breach notice sent by Licensor to Licensee), or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right was terminated by Licensor pursuant to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply Section 3.3(g) of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue for Licensee’s failure to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharmameet Minimum Net Sales as specified therein), its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, then: to the extent legally practicable, assign to Otsuka its right, title and interest that the Inventory Purchase Option is not exercised in and to each IND and all other regulatory filings full with respect to any all Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuingMerchandise subject thereto, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If if Licensee is not in default under this Agreement is terminated by GW Pharma (other than pursuant to Section 10.3(a3.3(g) of the Agreement), 10.3(bLicensee may use the Licensed Mxxx(s) or 10.4 or by Otsuka pursuant (“Royalty Option”) on a non-exclusive basis in connection with the sale of Approved Licensed Merchandise as to Section 10.5 all of which an Inventory Purchase Option was not exercised for the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days month period immediately following the expiration of the License Term or termination of this Agreementapplicable Purchase Option Period, each Party shall return to provided Licensee fully complies with the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide in connection with such disposal. In the event this Agreement is: (A) terminated by Licensor for survival of certain provisions following expiration or termination, the provisions of Article 1 any reason other than pursuant to Section 3.3(g) (allfor Licensee’s failure to meet Minimum Net Sales as specified therein), Article 4 or (dueB) terminated by Licensee after and/or in response to a breach notice sent by Licensor to Licensee, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 then: Licensee shall survive expiration or termination of this Agreementhave no Royalty Option.”
Appears in 1 contract
Samples: License Agreement (Movado Group Inc)
Effect of Expiration or Termination. (a) i. Upon expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement: (a) each Qualification shall automatically terminate, Company shall cease all references to all of its Qualifications and, except as expressly provided in Section 8(d)(ii) below, all Licenses shall automatically terminate and (b) the provisions of Sections 4, 5(d), 6, 7, 8(d) and 9 through 20 of this Agreement shall survive. Upon any revocation, expiration or termination of any specific Qualification, except as expressly provided in the remainder of this Section, Company shall cease all references to such Qualification and all Licenses shall automatically terminate except to the extent applicable to any Qualifications that remain in full force and effect.
ii. Notwithstanding the foregoing, for a period of twenty-four (24) months from the effective date of termination of any GP Test Tool Qualification (the “Tail Period”), Company may continue to use the Licensed Works and Titles to the extent necessary to provide Direct Test Tool Support to those End Users who were authorized to use the Test Tool covered by such terminated Qualification as of such termination date; provided that if Company continues to so use the Licensed Works or Titles during the Tail Period after notice of an Infringement Claim relating to such Test Tool or the Licensed Works or Titles used to create, develop or implement such Test Tool, then Company shall indemnify GP against any and all claims, causes of action or damages arising from or in connection with such use or the use of any related systems. Without in any way broadening the limitations set forth in the preceding sentence, Company’s use of Licensed Works, Titles or Test Tools as permitted by the preceding sentence during the Tail Period will continue to be subject to all restrictions, terms and conditions of this Agreement. Upon the earlier of Company’s ceasing to offer any Test Tools or the expiration of the Tail Period, Company will (A) make no further use of the Licensed Works or Titles (except to the extent Company may otherwise be entitled to use the same solely in its capacity as a member of GP), (B) return or destroy all copies of the Licensed Works in Company’s possession or under its control and expunge all electronic copies (except to the extent otherwise permitted by GP), (C) recall, or cause to be recalled, all Test Tools then in use by any third party and (D) destroy all marketing and other materials that depict or incorporate any of the Licensed Works or Titles.
Appears in 1 contract
Samples: Qualification and Listing Agreement
Effect of Expiration or Termination. (a) Upon Termination or expiration of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the License Termbenefit of either Party prior to such termination or expiration. Sections 1, all of the following will apply:
(i) All licenses 4.6, 7.3, 8, 9, 10, 11 and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 12 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to survive any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.
(b) Upon any termination of this Agreement by SG under Section 11.3, the licenses granted by GNE to SG in Section 2 shall thereafter automatically become perpetual; provided, however that SG shall continue to pay to GNE, for the remainder of the Term for each Licensed Product, royalties as set forth in Section 4.
(c) Upon any termination of this Agreement by GNE under Section 11.2 or 11.3, the licenses granted by GNE to SG in Section 2 shall terminate and SG, at GNE’s request, shall return to GNE all Materials and Technology.
(d) Any sublicense permitted under this Agreement, to the extent it is consistent with the rights and obligations due GNE hereunder, shall survive termination of this Agreement and be deemed a direct license from GNE provided that (i) the sublicensee is not in material breach of the terms of its sublicense at the time of such termination, (ii) upon termination of this Agreement, such sublicensee agrees in writing to be bound by all terms of this Agreement applicable to SG, and can reasonably show the capacity to comply with such terms to the same extent as if such sublicensee were an original party hereto, (iii) the obligations of GNE under such direct license shall not be greater than the obligations of GNE under this Agreement, and (iv) the scope of such direct license shall not be broader than the rights sublicensed by SG to such sublicensee.
Appears in 1 contract
Effect of Expiration or Termination. (a) Upon the effective date of expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder termination of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license licenses granted by Otsuka SteadyMed to GW Pharma under Section 2.3. of this Agreement Cardiome hereunder shall continue in full force terminate and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue revert to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW PharmaSteadyMed, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals rights and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations obligations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka Parties under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect, except as expressly set forth below in this Section 14.3 or in Section 14.4.
(iib) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on In the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion event of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement by SteadyMed pursuant to Section 14.2(a) to (d), or by Cardiome pursuant to Section 14.2(a) to (e), the following shall not apply (in addition to the provisions of Section 14.3(a) and 14.4):
(i) affect any other rights of either Party which may have accrued up Regulatory and Pricing Approvals. Cardiome shall, at Steadymed’s cost and written request, promptly: (A) transfer or assign, or cause to be transferred or assigned, to SteadyMed or its designee (or to the date extent transfer or assignment is not permitted by Applicable Law, take all reasonable actions to make available to SteadyMed or its designee the full benefits of) all Regulatory Applications, Regulatory Approvals, regulatory dossiers, applications for Pricing Approval, and Pricing Approvals, for Product in the Territory, whether held in the name of Cardiome, its Affiliate or a Sublicensee or Subdistributor; (B) provide to SteadyMed or its designee a complete copy of all of the foregoing documents, as well as copies of all correspondence with Regulatory Authorities or Pricing Authorities pertaining to Products in the Territory; and (C) take such termination other actions and execute such other instruments, assignments and documents as may be necessary to effect, evidence, register and record the transfer, assignment or other conveyance of rights under this Section 14.3(b)(i) to SteadyMed or its designee. Notwithstanding the above, if Cardiome cannot complete (iiA) preclude either Party from pursuing through (C) as set forth above due to Applicable Law or contracts that prohibit the same, Cardiome will take all rights and remedies it may have hereunder reasonable actions to make the above available to SteadyMed or SteadyMed’s designee at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this AgreementSteadyMed’s cost.
Appears in 1 contract
Samples: Exclusive License and Supply Agreement (Correvio Pharma Corp.)
Effect of Expiration or Termination. (a) Upon Termination of this Agreement for any reason (except as modified in Sections 9.5(b), 9.5(c) and 9.5(d) below), or expiration of the License Termthis Agreement, all of the following will apply:
not affect: (i) All licenses obligations, including the payment of any milestones, which have accrued as of the date of termination or expiration; and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shallrights and obligations which, at Otsuka’s electionfrom the context thereof, continue are intended to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 survive termination or expiration of this Agreement shall continue for the term of the Manufacturing Agreement, including Sections 3.2 and Supply Agreement so long as the Manufacturing 3.3, Articles VI, VIII, IX, X and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretionXI.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If CombinatoRx terminates this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b)9.2, then all of the following will apply:
(i) All licenses granted by CombinatoRx to Novartis and associated rights granted its Affiliates hereunder shall terminate and revert to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licensesCombinatoRx, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreementlicenses granted by Novartis and its Affiliates to CombinatoRx under Sections 3.1(a) and 3.3 shall terminate and revert to Novartis or such Affiliates. If and [*] PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. AN UNREDACTED VERSION OF THIS EXHIBIT HAS BEEN FILED WITH THE COMMISSION. to the extent that CombinatoRx Background Intellectual Property and/or CombinatoRx’s interest in Novartis Tool Compound Project Intellectual Property is required to develop or commercialize any Novartis Combination, Novartis Compound or drug product in a jurisdiction, Novartis and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) its Affiliates shall be due allowed to sell all made and partially made drug products in amounts reduced by *** percent (***%such jurisdiction(s) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) under the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms licenses set forth in Section 2.3and as set out below: (i) where 3.2 for a period of one year from the Agreement has been terminated under Section 10.3(b) date of termination; provided that the sale of such license shall continue drug products will be subject to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions terms of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the sameAgreement.
(c) If Novartis terminates this Agreement is terminated by GW Pharma pursuant to Section 10.3(a9.2 other than as a result of CombinatoRx’s breach of Sections 2.5(c), 10.3(b2.5(d), 2.5(e), 3.5(b) or 10.4 Article VIII, then: (A) all licenses granted by Novartis and its Affiliates to CombinatoRx hereunder shall terminate and revert to Novartis or such Affiliates, and (B) any amounts payable to CombinatoRx under Section 5.2 shall be reduced by Otsuka [*] percent ([*]%) as they become due. If Novartis terminates this Agreement pursuant to Section 10.5 9.2 as a result of CombinatoRx’s breach of Sections 2.5(c), 2.5(d), 2.5(e), 3.5(b) or Article VIII, then: (A) all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma Novartis and its Affiliates to Otsuka under Sections 2.1 and 2.4 of this Agreement CombinatoRx hereunder shall terminate and be of no further force revert to Novartis or effect.
such Affiliates, and (iiB) The license granted by Otsuka any amounts payable to GW Pharma CombinatoRx under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma 5.2 shall be entitled to a complete duplicate of reduced by [*] percent (or complete access to, [*]%) as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvalsbecome due.
(d) If Novartis terminates this Agreement pursuant to Section 9.4, then: (A) all licenses granted by Novartis and its Affiliates to CombinatoRx hereunder shall terminate and revert to Novartis or such Affiliates, and (B) CombinatoRx shall refund to Novartis a portion of the license granted by GW Pharma up-front payment made pursuant to Otsuka under Section 2.1 is terminated by Otsuka, in relation 5.1(a) according to a particular Licensed Product then the provisions schedule set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iiiforth [*] PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. AN UNREDACTED VERSION OF THIS EXHIBIT HAS BEEN FILED WITH THE COMMISSION. below within sixty (60) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) calendar days following CombinatoRx’s receipt of Novartis’ notice of termination pursuant to Section 9.4. For purposes of clarity, “Time after the expiration of the License Term or termination of this Agreement, each Party Effective Date” shall return refer to the other Party or destroy, upon date on which CombinatoRx receives notice (under the written request terms of the other Party, any and all Confidential Information Section 11.14) of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or Novartis’ termination of this Agreement shall not (i) affect any other rights pursuant to Section 9.4. Effective Date until six month anniversary of either Party which may have accrued up to the date Effective Date US $ 3,000,000 Six month anniversary until twelve month anniversary of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach Effective Date US $ 2,000,000 Twelve month anniversary until eighteen month anniversary of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.Effective Date US $ 1,000,000
Appears in 1 contract
Samples: Research Collaboration and License Agreement (Combinatorx, Inc)
Effect of Expiration or Termination. (a) Upon The expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 or earlier termination of this Agreement shall be deemed without prejudice to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms any rights or obligations of the Manufacturing Parties that may have accrued prior to such termination. Those provisions that by their terms or intent are required to survive the expiration or earlier termination of the Agreement in order to give effect to the intent of the Parties shall so survive. Without limiting the foregoing, the provisions of Sections 4.5, 6.3 and Supply Agreement for its term 8.3 and Otsuka ARTICLE 5, ARTICLE 7, ARTICLE 9 and ARTICLE 10 shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require survive the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 expiration or termination of this Agreement shall and continue for thereafter in accordance with and to the term extent of the Manufacturing and Supply Agreement so long their terms. Except as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDSotherwise expressly provided herein, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 termination of this Agreement in accordance with the provisions hereof shall continue not limit remedies that may otherwise be available at law or in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3equity.
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) Upon expiration or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder earlier termination of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be dueeach Party, but only in at the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments request of the Licensed Intellectual Propertyother, shall return all data, files, records and same, if not already other materials in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsukapossession or Control containing or comprising the other Party’s election, continue to supply Licensed Products to Otsuka on Confidential Information except that the terms legal department of the Manufacturing and Supply Agreement such Party may retain one copy solely for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the samearchival purposes.
(c) If Upon any termination of this Agreement is terminated by GW Pharma Intercept pursuant to Section 10.3(a), 10.3(b8.2(a) or 10.4 or by Otsuka PharmaZell pursuant to Section 10.5 all of the following will apply:
8.2(c), (i) The licenses PharmaZell shall return to Intercept all Intercept Materials, (ii) Intercept shall purchase from PharmaZell the amount of Supplied Material that is subject to Work Orders outstanding at the time of such termination, (iii) Intercept shall reimburse PharmaZell for work in process and associated rights granted Materials that PharmaZell has purchased for the purpose of supplying Supplied Material to Intercept in accordance with the delivered Work Orders, and (iv) Intercept shall pay PharmaZell’s direct cost for any such work in process in accordance with the Work Orders and PharmaZell’s purchase price from its suppliers for any such Materials ordered for such Work Orders that have a minimum of [**] shelf life and have been stored and controlled by GW Pharma PharmaZell per the Quality Agreement; provided, however that PharmaZell shall use reasonable best efforts to Otsuka under Sections 2.1 and 2.4 return such Materials to suppliers or use such Materials in the manufacture of product for third parties. In the event of termination of this Agreement by Intercept pursuant to Section 8.2(b), 8.2(c) or 8.2(d), at the request of Intercept, PharmaZell shall terminate fulfill all outstanding Work Orders for Supplied Materials prior to the effective date of such termination and be of no further force or effectto the extent not used to fulfill Work Orders at Intercept’s request, PharmaZell shall return to Intercept all Intercept Materials.
(iid) The license granted Except as and to the extent contemplated by Otsuka to GW Pharma under Section 2.3 8.3(c), upon expiration of this Agreement or any earlier termination of this Agreement, PharmaZell immediately shall continue cease all Manufacturing of Supplied Materials pursuant to this Agreement.
(e) Following expiration or termination of this Agreement, PharmaZell shall (i) provide Intercept with such reasonable cooperation and support with respect to regulatory matters as Intercept may require in full force and effect as order to dispose of previously purchased API, (ii) grant to Intercept a worldwide perpetual, irrevocable, non-exclusive royalty-free licenselicense (with the right to grant sublicenses) under know-how, patents and other intellectual property rights owned, licensed or otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of controlled by PharmaZell (or complete access to, any of its Affiliates) as appropriate) may be necessary or useful for the Otsuka Clinical Data purpose of making and all relevant Otsuka Know-How having made the API and all embodiments thereof, API Precursor and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, provide to Intercept copies of the provisions physical embodiment of Article 1 (all)those processes, Article 4 (dueprotocols, but unpaid obligations)procedures, Article 5 (methods, tests and other know-how, relating to the Manufacturing of the API and API Precursor. In addition, PharmaZell shall provide reasonable assistance to Intercept and its Affiliates with respect to assisting Intercept and its Affiliates in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination obtaining all necessary regulatory approvals and/or modifying existing Regulatory Approvals for the Manufacture of this Agreementthe API.
Appears in 1 contract
Samples: Manufacturing Agreement (Intercept Pharmaceuticals Inc)
Effect of Expiration or Termination. (a) Upon Termination or expiration of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the License Termbenefit of either Party prior to such termination or expiration and shall not release either party from any obligation that has accrued prior to such expiration or termination, all including without limitation any obligation to pay any amount which accrued or became due and payable under the terms and conditions of this Agreement prior to such expiration or termination. Sections 1, 2.10, 4.1, 4.2, 4.3, 4.9 (to extent provided therein), 7.3, 8.1, 9, 10 (to the following will apply:
(i) All licenses extent provided therein), 11.5 and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 12 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to survive any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.
(b) Upon any termination of this Agreement by any party for any reason, the licenses granted by PDL to SG in Section 2 shall terminate and SG shall discontinue all further research and development of Licensed Products. Furthermore, SG shall promptly return to PDL (or at PDL’s request destroy) all Confidential Information of PDL and all Cell Lines, PDL CD33 Antibodies and Materials in SG’s possession or control.
(c) Any sublicense permitted under this Agreement, to the extent it is consistent with the rights and obligations due PDL hereunder, shall, at such sublicensee’s option in its sole discretion, survive termination of this Agreement and be deemed a direct license from PDL provided that: (i) the sublicensee is not in material breach of the terms of its sublicense at the time of such termination; (ii) upon termination of this Agreement, such sublicensee agrees in writing to be bound by all terms of this Agreement applicable to SG, and can reasonably show the capacity to comply with such terms to the same extent as if such sublicensee were an original Party hereto; (iii) the obligations of PDL under such direct license shall not be greater than the obligations of PDL under this Agreement; and (iv) the scope of such direct license shall not be broader than the rights sublicensed by SG to such sublicense.
(d) In the event of any termination of this Agreement, other than termination by SG pursuant to Section 11.3 or 11.4, at PDL’s option, in its sole discretion upon written notice to SG within [***] after the effective date of termination, SG shall negotiate in good faith with PDL for an exclusive license (solely for the purpose of developing, manufacturing and commercializing Licensed Products) to any SG CD33 Patents and related know-how and intellectual property owned and controlled by SG that covers or is used in Licensed Products (or their development, manufacture or commercialization) under reasonable terms and conditions. If the Parties mutually agree on such terms and enter into such an exclusive license agreement, then SG shall transfer to PDL all of SG’s research, development, manufacturing and commercialization program for all Licensed Products (including all Second Generation CD33 Products and Second Generation CD33 Improvements). Subject to reasonable availability, SG shall also make its employees and relevant consultants reasonably available during the first year following termination to consult with qualified PDL personnel on issues and questions related to development and manufacturing of Licensed Products, provided that in no event shall SG be obligated to provide more than [***] and [***] per week thereafter in performing such activities. PDL shall pay SG at an annual rate of [***], for research, development, manufacturing, technology transfer or other [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. assistance to PDL hereunder, in [***] from the date of termination, and as reasonably requested by PDL for SG time allocated to such activities beyond [***], provided that such SG resources are available. Such FTE rate shall be increased by [***] of the Effective Date and upon every [***] thereafter during the Term. Such cooperation and assistance, as reasonably requested by PDL (or its designee), shall continue with as little disruption and delay as reasonably possible to the development, manufacture, and commercialization of Licensed Products (including, if applicable, by providing technology (including know-how) transfer, training and consultation and by transferring manufacturing processes and related technology). SG shall also transfer to PDL all applicable regulatory filings and approvals for Licensed Products together with all clinical data and similar information for Licensed Products. SG shall use commercially reasonable efforts to effect a transfer substantially in accordance with the foregoing from all of its applicable sublicensees, affiliates and contractors.
Appears in 1 contract
Effect of Expiration or Termination. (a) Upon the expiration or termination of this Agreement other than a termination by Interplay for a Default by UNIVERSAL, UNIVERSAL may continue to sell-off, on a non-exclusive basis, Product inventory remaining in UNIVERSAL's possession as of the License Termdate of termination or expiration, for a period of *** days after such expiration or termination.
(b) To the extent UNIVERSAL does not return inventory to Interplay, UNIVERSAL's customers will retain the right to sell all of their inventory of the following will apply:Products.
(c) Upon any termination of this entire Agreement or of any specific Product by Interplay due to a Default by UNIVERSAL, UNIVERSAL shall (i) All licenses immediately cease and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 desist from all further distribution of this Agreement shall be deemed to be paid-up such Product(s) (and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka UNIVERSAL hereby expressly agrees that Interplay shall have the right to terminate the Manufacture enjoin UNIVERSAL from conducting any further distribution and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, marketing activities in connection with such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(bProduct(s)), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of within *** percent (days thereafter, at *** cost, return to Interplay all inventory of such Product(s) then in UNIVERSAL's possession. In the event UNIVERSAL tenders any Product units to Interplay and Interplay does not accept such Product units, UNIVERSAL may require that the carrier return such inventory to UNIVERSAL's warehouse(s) and Interplay will then owe UNIVERSAL, in addition to the amount due for such Product units ***%) on net sales of products made by GW Pharma, its Affiliates . UNIVERSAL will not be obligated to retender any and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner all *** Portions of Terms represented by this page symbol are considered confidential. These confidential terms have been omitted pursuant to a request for Confidential Treatment Request filed with the Securities and Exchange Commission ("SEC") and have been filed separately with the CommissionSEC. comparable to that set forth Product units until Interplay pays in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and cash all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka amounts then due UNIVERSAL under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed ProductsAgreement, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for which time UNIVERSAL shall promptly retender such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory ApprovalsProducts.
(d) If a portion of UNIVERSAL may retain and apply the license granted by GW Pharma General Reserve against amounts owed to Otsuka UNIVERSAL under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request and UNIVERSAL will repay any unused portions of the other PartyGeneral Reserve, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunderin Section 6.8 above.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.
Appears in 1 contract
Samples: Distribution Agreement (Interplay Entertainment Corp)
Effect of Expiration or Termination. (a) i. Upon expiration of the License Term, all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;
(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;
(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;
(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3
(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:
(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.
(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.
(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.
(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.
(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:
(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.
(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.
(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.
(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Xxxxxxxx & Xxxxxxxx within thirty (30) days from the Closing Date to be held by Xxxxxxxx & Xxxxxxxx in escrow and Xxxxxxxx & Xxxxxxxx will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Xxxxxxxx & Xxxxxxxx as escrow agent to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Xxxxxxxx & Xxxxxxxx and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.
(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.
(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.
(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement: (a) each Qualification shall automatically terminate, Company shall cease all references to all of its Qualifications and, except as expressly provided in Section 8(d)(ii) below, all Licenses shall automatically terminate and (b) the provisions of Sections 4, 5(d), 6, 7, 8(d) and 9 through 20 of this Agreement shall survive. Upon any revocation, expiration or termination of any specific Qualification, except as expressly provided in the remainder of this Section, Company shall cease all references to such Qualification and all Licenses shall automatically terminate except to the extent applicable to any Qualifications that remain in full force and effect.
ii. Notwithstanding the foregoing, for a period of twenty-four (24) months from the effective date of termination of any GP Test Tool Qualification (the “Tail Period”), Company may continue to use the Licensed Works and Titles to the extent necessary to provide Direct Test Tool Support to those End Users who were authorized to use the Test Tool covered by such terminated Qualification as of such termination date; provided that if Company continues to so use the Licensed Works or Titles during the Tail Period after notice of an Infringement Claim relating to such Test Tool or the Licensed Works or Titles used to create, develop or implement such Test Tool, then Company shall indemnify GP against any and all claims, causes of action or damages arising from or in connection with such use or the use of any related systems. Without in any way broadening the limitations set forth in the preceding sentence, Company’s use of Licensed Works, Titles or Test Tools as permitted by the preceding sentence during the Tail Period will continue to be subject to all restrictions, terms and conditions of this Agreement. Upon the earlier of Company’s ceasing to offer any Test Tools or the expiration of the Tail Period, Company will
(A) make no further use of the Licensed Works or Titles (except to the extent Company may otherwise be entitled to use the same solely in its capacity as a member of GP), (B) return or destroy all copies of the Licensed Works in Company’s possession or under its control and expunge all electronic copies (except to the extent otherwise permitted by GP), (C) recall, or cause to be recalled, all Test Tools then in use by any third party and (D) destroy all marketing and other materials that depict or incorporate any of the Licensed Works or Titles.
Appears in 1 contract
Samples: Qualification and Listing Agreement