Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines.
Appears in 5 contracts
Sources: Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc), Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc), Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc)
Right of First Negotiation. If during (a) For a period of [***] years from the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent Effective Date (the “ROFN NoticePeriod”), Erasca shall have an exclusive first right to negotiate with Katmai to enter into a definitive agreement governing the research, development and commercialization of products (x) whose principal mode of action is inhibition of epidermal growth factor receptor(s), other than Licensed Products, (y) that are Covered by Existing Licensed Patent Rights or that are Covered by other Patent Rights acquired by Katmai from the [***] after the Effective Date, and (z) that may be suitable as a basis for therapeutic or diagnostic products or services in the Neuro-oncology Field (the “ROFN Products”), including without limitation rights for ROFN Products Katmai obtains pursuant to any license agreement (a “ROFN Product Agreement”) between Katmai and GSK and/or GSK Bio thereafter the [***] as follows:
(b) During the ROFN Period, Katmai shall have notify Erasca in writing upon the exclusive right earlier of first negotiation (x) Katmai’s election to obtain pursue development of an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How ROFN Product or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technologyy) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from (or as the receipt Parties otherwise agree) after Katmai’s entry into a ROFN Product Agreement, and provide to Erasca a summary of the ROFN Notice Product Agreement and the related Patent Rights and ROFN Product. Katmai shall not grant to inform Liquidia any Third Party any right to develop and commercialize a ROFN Product, or engage in writing any negotiations with any Third Party the terms of any agreement pursuant to which such Third Party would obtain such a license or other right to develop and commercialize the ROFN Product, until the applicable Release Date (as defined below), whereupon Erasca shall have no further rights under this Section 2.5 with respect to the applicable ROFN Products and ROFN Product Agreement. Erasca shall not use information included in any disclosure by Katmai related to a ROFN Product Agreement or ROFN Product to enter into discussions with the [***] or the Investigators or for any other purpose, other than exercising its election rights of first negotiation under this Section 2.5. If within sixty (60) days after receiving such written notice from Katmai, Erasca delivers to Katmai a written notice that Erasca desires to negotiate with Katmai the terms of an agreement pursuant to which Erasca would obtain rights to develop and commercialize such ROFN Products, then until the Release Date, Katmai and Erasca will negotiate in good faith the terms of such exclusive license, and another thirty (30) days agreement. The “Release Date” shall mean the date that is the first to submit to Liquidia an initial proposal for occur of the date upon which Erasca notifies Katmai in writing that it is no longer interested in negotiating the terms of such exclusive license. If GSK an agreement pursuant to which it would obtain the rights to develop and commercialize the relevant ROFN Products or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date that is sixty (60) days after Katmai delivers to Erasca notice in writing of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How (x) or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Periody) shall be thereafter excluded from and not subject to above. Erasca’s rights under this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant 2.5 shall apply on a nonROFN Product Agreement-exclusive license to the Joint Inhaled Collaboration Knowby-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription ROFN Product Agreement basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines.
Appears in 4 contracts
Sources: Exclusive License Agreement (Erasca, Inc.), Exclusive License Agreement (Erasca, Inc.), Exclusive License Agreement (Erasca, Inc.)
Right of First Negotiation. 2.3.1 If during the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires Company seeks to grant a nonsublicense (an “Out-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting License”) to a Third Party from whom Liquidia for development and/or commercialization of AMG 842 (or, to the extent Company has received de-prioritized AMG 842, the backup Product thereto for which Company is actively seeking to fulfill its diligence obligation hereunder pursuant to Section 5.2 (Diligence)), then Company shall notify Amgen in advance in writing and provide a term sheet or letter non-confidential summary of intent the Product that is the subject of the proposed sublicense, as well as the intended scope (which the Parties agree shall be initially for worldwide rights) of the Out-License (a “Transaction Notice”). If Amgen desires to evaluate such Out-License, then Amgen shall notify Company within [*] days of its receipt of the Transaction Notice (a “Negotiation Notice”). Promptly after Company’s receipt of a Negotiation Notice, Company shall provide Amgen with a confidential summary of the Product Company is seeking to Out-License (a “Summary”), including existing material clinical and preclinical data, as well as such other information in Company’s possession that Amgen may reasonably request, which Summary shall be deemed to be Confidential Information of Company under this Agreement. For [*] following Amgen’s receipt of a Summary (the “ROFN NoticeExclusivity Period”) and GSK and/or GSK Bio thereafter ), Amgen shall have the an exclusive right of first negotiation to obtain negotiate an exclusive, worldwide, sublicensable royalty-bearing license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights such Product from Company. If Amgen (which may include Liquidia Technologyi) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in does not deliver a Negotiation Notice to Company within the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the [*] period after receipt of the ROFN Notice Negotiation Notice, (ii) does not deliver to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial Company a written proposal for the terms of an Out-License to Amgen during the Exclusivity Period, or (iii) declines in writing the Out-License after review of the Summary, then Amgen shall be deemed to have waived its rights under this Section 2.3 (Right of First Negotiation) with respect to such exclusive licenseProduct. If GSK or GSK Bio delivers Amgen and Company do not mutually agree on the terms of an Out-License for such notice during the first thirty (30) day period and submits the initial proposal Product to Amgen within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Exclusivity Period, then Liquidia Company shall be free to negotiate an Out-License for such Product with any Third Party Party, subject to the terms of Section 2.2 (Sublicenses) and Section 2.3.2. For clarity, an Out-License shall not include the grant of a sublicense to a contract manufacturer or a contract research organization for a non-exclusive license within the same applicable field that was the subject purpose of negotiations with GSK manufacturing or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license developing Products for Company or to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Noticedistributor selling finished Product purchased from Company, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How this Section 2.3 (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration Right of Negotiation PeriodFirst Negotiation) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How restrict Company in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested manner with respect to portions such a sublicense.
2.3.2 If Company’s board of this agreement directors approves the initiation of a process for (i) a Sale Transaction or (ii) a response to an unsolicited offer for an Out-License, in each case related to Company’s rights in AMG 842 (or, to the extent Company has de-prioritized AMG 842, the backup Product thereto for which Company is actively seeking to fulfill its diligence obligation hereunder pursuant to Section 5.2 (Diligence)), then Company shall notify Amgen concurrently with any other notifications required hereunder (provided that a signed letter sent via electronic or facsimile transmission shall qualify as indicated by “such written notice) and provide the intended scope (i.e., field, territory and other relevant terms) of the Out-License and/or Sale Transaction. [***]” and such ] = Certain confidential portions have information contained in this document, marked by brackets, has been deleted omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended. basis.
2.3.3 Upon the completion of an Initial Public Offering (as defined in the investor rights agreement to be entered into by the Parties) or a sale of all or substantially all of Company’s assets or business, or vaccine or biological products (including biosimilar products). For purposes of Amgen’s rights under this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines2.3 (Right of First Negotiation) shall terminate.
Appears in 3 contracts
Sources: Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.)
Right of First Negotiation. If during During the Inhaled Option Period and/or Vaccines Option PeriodTerm, Liquidia desires to grant a non-exclusive license to its interest each Company Licensee shall promptly notify the applicable Pfizer Licensor in writing in the Joint Inhaled Collaboration Know-How event that it invents or Joint Vaccines Collaboration Know-How as described otherwise generates any improvements, modifications, or upgrades to any Third Party IP that are licensed to a Pfizer Licensor pursuant to the Scripps Agreement or any Patent Rights that, from time to time, the Parties identify as, and agree in writing are, the Patent Rights to which this Section 11.4(b)(iiishall apply (“Scripps Improvements”), then it shall first notify GSK and GSK Bio . Upon receipt of such desire in writingwritten notice from such Company Licensee, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio Pfizer Licensor shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia notify such Company Licensee that it intends to enter into negotiations with such Company Licensee to be granted exclusive rights with respect thereto. If such Pfizer Licensor does not so notify such Company Licensee in writing of its election to negotiate the terms of within such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period that it intends to enter into negotiations with such Company Licensee, then such Company Licensee shall be permitted to license any Patent Rights or Know-How that it Controls and submits that relates to the initial proposal Scripps Improvements to any Third Party on any terms (subject to the terms and conditions of the Scripps Agreement). In the event that such Pfizer Licensor provides such Company Licensee with such a written notice that it intends to enter into negotiations with such Company Licensee, such Pfizer Licensor and such Company Licensee shall enter into good faith negotiations in order to conclude an agreement within ninety (90) days from expiration of the second thirty (30) day period described in the foregoing sentence. In the event that such Pfizer Licensor and Company Licensee do not enter into a definitive written agreement within such ninety (90) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to Company Licensee may thereafter negotiate with any Third Party for a non-exclusive license within the same applicable field Parties; provided that was the subject of negotiations such Company Licensee and its Affiliates may not enter into such an agreement with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; providedParty on terms which, that if Liquidia grants such non-exclusive license taken as a whole, are substantially identical to, or materially more favorable to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than than, the terms last proposed offered by GSK or GSK Bio such Company Licensee to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesPfizer Licensor.
Appears in 2 contracts
Sources: Patent and Know How License Agreement (Zoetis Inc.), Patent and Know How License Agreement (Zoetis Inc.)
Right of First Negotiation. If If, during the Inhaled Option Period and/or Vaccines Option period from the Closing Date until the ten (10) year anniversary thereof (the “ROFN Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii”), then it shall first notify GSK and GSK Bio Seller (or any of such desire in writing, describing in reasonable detail the scope of the license its Affiliates) determines that it is interested in granting entering into an arrangement with an unaffiliated Person (hereinafter a “Third Party”) to a Third Party from whom Liquidia has received a term sheet sell substantially all of the assets of Seller, Seller’s silicon nitride spinal implant manufacturing technology including any of the SN Manufacturing Patents, or letter of intent the Manufacturing Facility (any such assets, the “ROFN NoticeAcquisition Target”), Seller (or any of its Affiliates, as applicable) and GSK and/or GSK Bio thereafter shall have the exclusive give Buyer a right of first negotiation to obtain an exclusive, worldwide, sublicensable license acquire such Acquisition Target as follows:
(a) Seller shall give written notice to Liquidia’s Buyer of its (or any of its Affiliates’) interest in selling an Acquisition Target and specify the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for identity of the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field)Acquisition Target. GSK or GSK Bio Buyer shall have thirty (30) days from the after receipt of the ROFN Notice such notice to inform Liquidia in writing of its election elect to negotiate the terms of enter into negotiations for an arrangement with respect to such exclusive license, and another thirty (30) days Acquisition Target by delivering written notice to submit to Liquidia an initial proposal for the terms of Seller within such exclusive licenseperiod. If GSK Buyer declines to pursue negotiations or GSK Bio delivers such does not reply to Seller’s notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK Seller (or GSK Bioany of its Affiliates, for a period not to exceed six (6as applicable) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate and enter into an arrangement with respect to such Acquisition Target with a Third Party.
(b) If Buyer exercises its negotiation rights in accordance with Section 9.7(a), then for an additional sixty (60) day period, Seller shall conduct negotiations on an exclusive basis with Buyer diligently and in good faith to reach an agreement with Buyer. If the parties have not reached an agreement at the end of such sixty (60) day period, Buyer shall give Seller a written notice setting forth Buyer’s final offer to purchase the Acquisition Target setting forth the purchase price for the Acquisition Target and all other material terms of its offer (the “Final Offer”). If Seller (or any of its Affiliates, as applicable) rejects the Final Offer, it shall thereafter be free to negotiate and enter into an arrangement with respect to such Acquisition Target with a Third Party for as provided in Section 9.7(c) below.
(c) If Seller and Buyer fail to negotiate a non-exclusive license written agreement pursuant to Section 9.7(b) above within the same applicable field that was period provided therein, Seller (or any of its Affiliates, as applicable) shall be free to enter into an arrangement for the subject sale of negotiations the Acquisition Target with GSK or GSK Bio, and to grant such non-exclusive license to any a Third Party; provided, however, that if Liquidia grants such non-exclusive license to during the ROFN Period, Seller shall not, and shall cause its Affiliates not to, enter into an arrangement with a Third Party within nine (9) months after the expiration of Negotiation Period, then the with respect to such Acquisition Target on terms of such Third Party license shall be no less favorable to Liquidia Seller and its Affiliates than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to Final Offer (a “Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as Offer”) without first offering to sell the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject Acquisition Target to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio Buyer on the terms set forth abovein the Third Party Offer (the “Re-Offer”). Subject Buyer shall have ten (10) Business Days following its receipt of the Re-Offer to agree to purchase the Acquisition Target on the terms set forth in in the Third Party Offer by delivering notice of same to Seller (or any of its Affiliate, if applicable). Buyer and Seller shall work expeditiously to close such transaction within ninety (90) days following Buyer’s acceptance of the Re-Offer. Seller’s performance of its obligations set forth in this Section 4.4 below, Liquidia 9.7 and the payment of Buyer’s damages for any breach of this Section 9.7 by Buyer shall be free to secured by Seller’s grant non-exclusive licenses to its of a security interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside Acquisition Targets pursuant to a security agreement, in the field form attached hereto as Exhibit F (the “ROFN Security Agreement”). The rights and obligations of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, the parties set forth in Section 1.6 and the right of first negotiation described Section 1.8 shall remain in full force and effect if Buyer exercises its rights under this Section 4.3 9.7 but Buyer and Seller (or its Affiliates, if applicable) fail to consummate a sale transaction. In addition, such rights and obligations shall only apply in survive the field sale of prescription pharmaceutical products, pharmaceutical products sold an Acquisition Target to a Third Party. Seller shall condition the sale of an Acquisition Target to a Third Party on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions the Third Party’s express assumption of this agreement as indicated by “[***]” Seller’s obligations under Section 1.6 and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines1.8.
Appears in 2 contracts
Sources: Asset Purchase Agreement (AMEDICA Corp), Asset Purchase Agreement (AMEDICA Corp)
Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the This Agreement includes an exclusive right of first negotiation (the “ROFN”) for ImmunoGen to obtain an exclusiverights to develop or commercialize, worldwideeither alone or with Licensee, sublicensable license to Liquidiathe Product in North America. Upon Licensee’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, completion of a Phase 2 Clinical Trial for a Product and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during upon the first thirty to occur of (30i) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively Licensee notifying ImmunoGen that its Board of Directors has directed management to undertake in good faith with GSK efforts to identify potential licensees or GSK Biocollaborators to develop and commercialize the Product or (ii) the date upon which the Licensee provides ImmunoGen a copy of the final and complete set of locked clinical trial data tables, figures, listings and safety reviews including, but not limited to, all statistical analyses and related data as per the clinical trial protocol and related statistical analysis plan (the “Phase 2 Clinical Trial Results”) for such Phase 2 Clinical Trial, Licensee shall notify ImmunoGen and for a period of [***] thereafter, ImmunoGen may exercise its ROFN by notifying Licensee in writing (the “lmmunoGen Option Exercise Notice”). If ImmunoGen does not exercise the ROFN during such [***] period, then Licensee shall be free to exceed six (6) months from GSK’s offer the opportunity to obtain a license to develop or GSK Biocommercialize the Product in North America to any third party and ImmunoGen shall have no further rights to the Product. If ImmunoGen exercises the ROFN, the Parties shall negotiate in good faith on an exclusive basis for up to [***] after the date of Licensee’s receipt of the ROFN ImmunoGen Exercise Option Notice (the “ImmunoGen License Negotiation Period”), . During this time the Parties would negotiate the terms under which Liquidia will this Agreement may be terminated and an agreement pursuant to which Licensee would grant such ImmunoGen an exclusive license (the “lmmunoGen Exclusive License”) with the right to GSK sublicense, under the Licensee IP to use, Develop, Commercialize and Manufacture the Products (and Compounds to the extent included or GSK Bioincorporated, or intended to be included or incorporated, in a Product) in North America. During the ImmunoGen License Negotiation Period, Licensee shall not offer the opportunity to obtain a license to develop or commercialize the Product in North America to any other third party. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license Parties have not entered into the ImmunoGen Exclusive License by the end of the ImmunoGen License Negotiation Period, then Liquidia Licensee shall be free to negotiate with any Third Party for offer the opportunity to obtain a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to develop or commercialize the Product in North America to any Third Partythird party and ImmunoGen shall have no further rights to the Product; provided, that if Liquidia grants such non-exclusive license to however, for a Third Party within nine (9) months after the expiration period of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” ] after the ROFN Termination Date, Licensee agrees that if the financial terms and conditions offered to such confidential portions third party would, taken as a whole, be materially less favorable to Licensee than the last written offer proposed by ImmunoGen, then Licensee shall so notify ImmunoGen and ImmunoGen shall have been deleted and filed separately with the Securities and Exchange Commission right to send Licensee a new written notice to re-commence negotiations within [***] after receiving Licensee’s notice. If ImmunoGen provides such notice within such time period, the Parties shall negotiate for another [***] period (during which Licensee shall not offer the opportunity to any third party to obtain a license, or enter into an agreement pursuant to Rule 24b-2 which a third party would obtain the right to develop or commercialize the Product in North America) the terms of the Securities Exchange Act of 1934, as amendedImmunoGen Exclusive License based upon the terms and conditions offered to the third party. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products The Parties hereby acknowledge and agree that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesneither Party shall have an obligation to enter into an ImmunoGen Exclusive License.
Appears in 2 contracts
Sources: License Agreement (Fusion Pharmaceuticals Inc.), License Agreement (Fusion Pharmaceuticals Inc.)
Right of First Negotiation. If during the Inhaled Option Exercise Period and/or Vaccines Option Period, Liquidia desires expires without exercise by Licensee of either or both Options pursuant to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii3.1(b), then it until the earlier of (i) June 30, 2024 and (ii) the three-year anniversary of the consummation of the Qualifying Merger, Licensor shall grant Licensee a right of first notify GSK negotiation to license the Tier B Patents and GSK Bio Tier C Patents, as applicable, on substantially the same terms as this Agreement to Develop, Commercialize and Manufacture the Tier B Products and/or Tier C Products in Europe (the “ROFN License”). The exclusive negotiating period will last for sixty (60) days, subject to each Party’s obligation to negotiate in good faith the terms of such desire in writing, describing in reasonable detail the scope license. The mechanics of the license it is interested in granting right of first negotiation are as follows:
(a) If Licensor or its Affiliates intends to enter into discussions or negotiations with a Third Party from whom Liquidia has received a term sheet or letter with respect to the ROFN License, Licensor shall provide written notice to Licensee of intent its intention to Licensee (the “ROFN Notice”).
(b) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio Licensee shall have thirty (30) days from the after receipt of the ROFN Notice to inform Liquidia in writing provide written notice to Licensor of its election interest in entering into negotiations for the ROFN License together with an initial term sheet, including proposed financial terms, for the ROFN License (a “ROFN Proposal”). If Licensee provides a ROFN Proposal, then for a period of sixty (60) days from Licensor’s receipt of the ROFN Proposal (“ROFN Period”), Licensee or its Affiliate will have the exclusive right to negotiate terms in which it will obtain the ROFN License from Licensor or its Affiliate. Such Parties shall negotiate in good faith the terms for the ROFN License. If, at the end of the ROFN Period, such exclusive licenseParties are unable to reach agreement on the ROFN License, and another Licensor shall have no further obligation to Licensee concerning the ROFN License pursuant to this Section 3.2; provided, that Licensor shall not, within sixty (60) days of the end of the ROFN Period, offer to grant the ROFN License to a Third Party on more favorable terms, taken as a whole, than those last offered to Licensor during the ROFN Period without first offering those terms to Licensee, which Licensee shall have thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive licenseaccept or reject. If GSK or GSK Bio delivers such notice For clarity, if Licensee does not provide Licensor with a ROFN Proposal during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia Licensor shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not have no further obligation to exceed six (6) months from GSK’s or GSK Bio’s receipt of Licensee concerning the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesLicense thereafter.
Appears in 2 contracts
Sources: License Agreement (Jaguar Health, Inc.), License Agreement (Jaguar Health, Inc.)
Right of First Negotiation. (a) If during after the Inhaled Option Period and/or Vaccines Option PeriodEffective Date PTI develops, Liquidia desires has developed or otherwise comes to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Control Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii)Patent Rights outside of the Collaboration, then it shall first notify GSK and GSK Bio PTI initiates the use or practice of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, Patent Rights as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt part of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of Collaboration, or either Party otherwise determines that such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-HowPatent Rights are necessary or useful to Biogen Idec to Develop one or more Licensed Products that Biogen Idec is actively Developing or Commercializing (“Additional Intellectual Property”), as then PTI will promptly notify Biogen Idec in writing of such Additional Intellectual Property, and Biogen Idec will have [***] from its receipt of such notice to determine whether it wishes to enter into negotiations with PTI for a license under such Additional Intellectual Property to research, Develop, manufacture, use, sell and import such applicable Licensed Product(s) in the case Field and for no other purpose. If Biogen Idec notifies PTI in writing that it would like to enter into negotiations for such license, the Parties will negotiate in good faith for a period of up to [***] to reach agreement on a license agreement for such Additional Intellectual Property. If the Parties are able to enter into such a license agreement, then the Parties’ respective rights and obligations with regard to such Additional Intellectual Property will be set forth in such agreement. If (i) Biogen Idec informs PTI that it does not wish to enter into negotiations with PTI for an exclusive license under such Additional Intellectual Property, (ii) Biogen Idec fails to provide such notice that it wishes to enter into negotiations with PTI for an exclusive license under such Additional Intellectual Property within the required [***] period, or (iii) Biogen Idec provides notice that it wishes to enter into negotiations with PTI for an exclusive license under such Additional Intellectual Property within the required [***] period, but the Parties fail to come to agreement on such a license agreement within the required [***] period then, in each case, PTI will have no further obligations to Biogen Idec with regard to the applicable Additional Intellectual Property; except that, PTI may benot license such Additional Intellectual Property to research, Develop, manufacture, use, sell and import the applicable Licensed Product(s) on terms that arises during are materially less favorable to PTI in the Inhaled Collaboration Term or Vaccine Collaboration Termaggregate than those offered by Biogen Idec in its final offer for a period of an additional [***].
(b) Notwithstanding the foregoing, as in the case may be, including after the date event of the ROFN Noticeacquisition of PTI, and all such Joint Inhaled Collaboration the Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How and Patent Rights of PTI that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not are subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to in Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration 7.6(a) will not include (i) any Know-How or Joint Vaccine Collaboration Know-How outside Patent Rights Controlled by the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by acquiring CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]” and such confidential portions have been deleted and filed separately with ”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. entity immediately prior to the Securities and Exchange Commission pursuant to Rule 24b-2 consummation of the Securities Exchange Act of 1934acquisition or (ii) any Know-How or Patent Rights that are developed or acquired by the acquiring entity following such acquisition, as amended. basisexcept for any such Know-How or Patent Rights that result from, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3are acquired in support of, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesthe Collaboration.
Appears in 1 contract
Right of First Negotiation. If during at any time prior to the Inhaled Option Period and/or Vaccines Option Periodtenth anniversary of the Effective Time, Liquidia desires (A) FMC or any Affiliate of FMC shall develop any new technology, whether patented or a trade secret (such party developing such new technology, hereinafter referred to grant a non-exclusive license to its interest in as the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii“inventor”), then it and the Inventor intends to sell or license such technology to a third party for applications in, or with a material special relationship to, Nutritional Substances and/or Pharmaceutical Substances outside of the Renal Business, the Inventor shall first notify GSK advise FAG of its intent to sell or license such technology and GSK Bio shall negotiate with FAG in good faith for the purpose of agreeing with FAG on either terms of a sale to FAG of such desire in writing, describing in reasonable detail technology or of a license granting FAG rights to use such technology for the scope commercialization of Nutritional Substances and/or Pharmaceutical Substances outside of the license it is interested in granting Renal Business. If the Inventor and FAG are unable to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the agree on mutually satisfactory terms of such exclusive sale or license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during after good faith negotiations, FAG shall have no further rights in or to such technology and the Inhaled Collaboration Term Inventor shall be free to sell or Vaccine Collaboration Termlicense such technology to third parties free and clear of any rights of FAG therein; (B) FAG or any Affiliate of FAG shall develop any new technology, whether patented or a trade secret (such party developing such new technology, hereinafter referred to as the “inventor”), and the Inventor intends to sell or license such technology to a third party for applications in, or with a material special relationship to, the Renal Business, the Inventor shall first advise FMC of its intent to sell or license such technology and shall negotiate with FMC in good faith for the purpose of agreeing with FMC on either terms of a sale to FMC of such technology or of a license granting FMC rights to use such technology in the Real Business. If the Inventor and FMC are unable to agree on mutually satisfactory terms of such sale or license, as the case may be, including after good faith negotiations, FMC shall have no further rights in or to such technology and the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia Inventor shall be free to grant non-exclusive licenses sell or license such technology to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field third parties free and clear of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right rights of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesFMC therein.
Appears in 1 contract
Sources: Post Closing Covenant Agreement (Fresenius Medical Care AG & Co. KGaA)
Right of First Negotiation. If during During the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope two years of the license it is interested in granting Term of this Agreement, AspenBio grants to Merial a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusivedistribute, worldwidemarket and sell all future animal health products developed by AspenBio ("Right of First Negotiation"). AspenBio shall notify Merial of future animal health products it intends to develop, sublicensable license distribute, market, and sell ("Product Notice"). Within ten business days of a request by AspenBio, and prior to Liquidia’s disclosure of any information regarding such future animal health products, Merial shall sign a confidentiality agreement whereby Merial agrees to maintain in confidence and not to use any information relating to such animal health products disclosed by AspenBio. To exercise the Right of First Negotiation, Merial shall provide AspenBio with notice of its interest in pursuing negotiations ("Notice of Interest") within 60 days of receipt of any Product Notice from AspenBio. In the Joint Inhaled Collaboration Knowevent that Merial does not enter into a confidentiality agreement in such time period, the Right of First Negotiation shall terminate immediately. The Notice of Interest shall be accompanied by a non-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful refundable payment of $50,000 to AspenBio to exercise the Right of First Negotiation granted under this Section 3.5 for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) 30 days from the receipt Notice of Interest. Upon the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms expiration of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) -day period, Liquidia Merial may extend the Right of First Negotiation granted under this Section 3.5 for up to two additional 30-day periods by making an additional non-refundable payment of $50,000 for each such 30-day extension prior to the expiration of the Right of First Negotiation. After timely receipt of a Notice of Interest and the non-refundable payment or payments described above, AspenBio shall not enter into negotiations with any third parties while the Right of First Negotiation is in effect, provided, that the Right of First Negotiation may not be extended for more than 90 days following the date of receipt of a Notice of Interest (the "Negotiation Period") and during such Negotiation Period AspenBio and Merial each shall negotiate exclusively in good faith with GSK faith. In the event that Merial does not deliver a timely Notice of Interest or GSK Bio, for a period not no final agreement is consummated prior to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end expiration of the Negotiation Period, then Liquidia AspenBio shall be free to negotiate and enter into agreements with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK third parties to distribute or GSK Bio, and to grant market such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidiaanimal health product. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described Nothing in this Section 4.3, either 3.5 shall prevent AspenBio from conducting additional research and testing and market research and analysis (alone or in conjunction with third parties) prior to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on termination of the terms set forth Right of First Negotiation described above. Subject This Section 3.5 shall not apply to Section 4.4 below, Liquidia shall be free animal health products for which AspenBio receives a proposal to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basisdevelop for, or biological products (including biosimilar products) at any timeco-develop with, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesindependent third parties.
Appears in 1 contract
Right of First Negotiation. If during Depomed shall notify Santarus in writing in the Inhaled Option Period and/or Vaccines Option Period, Liquidia event that Depomed desires to grant a non-exclusive divest itself of its rights to the Product in the Territory (e.g., by asset sale or product license to its interest in the Joint Inhaled Collaboration Know-How a Third Party) or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to grant rights to a Third Party from whom Liquidia has received to develop or commercialize a term sheet or letter pharmaceutical product containing metformin and another generic active pharmaceutical ingredient (i.e., an active pharmaceutical ingredient that is produced and distributed within the Territory without composition of intent matter patent protection for the compound) in combination with Depomed’s proprietary AcuForm drug delivery technology incorporated within the Products (a “Combination Product”). If Santarus notifies Depomed in writing within [***] days after receipt of such notice (the “ROFN NoticeEvaluation Period”) that Santarus is not interested in obtaining all of Depomed’s rights in and GSK and/or GSK Bio thereafter to the Products or the applicable Combination Product (such rights, “Metformin Product Rights”), or if Santarus fails to notify Depomed of Santarus’ interest in obtaining the Metformin Product Rights, in either case prior to the expiration of the Evaluation Period, then Depomed shall have no further obligation to Santarus under this Agreement with respect to the exclusive right applicable Metformin Product Rights. If Santarus is interested in obtaining the Metformin Product Rights, it *** 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. shall so notify Depomed in writing prior to the expiration of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicableEvaluation Period, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the upon Depomed’s receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period Santarus and submits the initial proposal within the second thirty (30) day period, Liquidia Depomed shall negotiate exclusively in good promptly commence good-faith with GSK or GSK Bionegotiations, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of [***] days and such longer period as may be mutually agreed upon by the ROFN Notice parties in writing in the event the parties have made material progress in the negotiations (the “Negotiation Period”), regarding the commercially reasonable terms under of an agreement pursuant to which Liquidia will grant such exclusive license to GSK or GSK BioSantarus shall obtain the Metformin Product Rights. If GSK or GSK Bio Depomed and Liquidia Santarus fail to reach a binding written enter into an agreement for the exclusive license by Metformin Product Rights prior to the end expiration of the Negotiation Period, then Liquidia Depomed shall be free thereafter have the right to negotiate and enter into an agreement with any a Third Party for granting the Metformin Product Rights to a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; providedprovided that, that if Liquidia grants such non-exclusive license to for a Third Party within nine (9) months after the expiration period of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” , any such agreement may not be on terms and such confidential portions have been deleted conditions materially more favorable to the Third Party than the terms and filed separately conditions last offered by Santarus prior to the termination of discussions with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amendedDepomed. basis, or vaccine or biological products (including biosimilar products). For purposes The provisions of this Section 4.313.1 shall not apply to, and Depomed shall have no obligation to Santarus under this Section 13.1 in respect of, any acquisition of Depomed by a Third Party, any merger or consolidation with or involving Depomed, any acquisition by a Third Party of any material portion of the stock of Depomed, or any acquisition by a Third Party of a material portion of the assets of Depomed in addition to the Products or any Combination Product (“biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesMerger Transaction”).
Appears in 1 contract
Sources: Promotion Agreement (Santarus Inc)
Right of First Negotiation. If during Parent will provide Seller a written notice (an “Initial Notice”) of each Marketing Approval (or a similar or an equivalent approval) by the Inhaled Option Period and/or Vaccines Option PeriodEuropean Medicines Agency or the Brazilian Health Surveillance Agency (or a similar, Liquidia desires equivalent or successor Governmental Body) for a particular indication of any Lixivaptan Product (each such particular indication (an “Approved Indication”)) in any portion of Europe, Brazil, Russia or the Commonwealth of Independent States (the “ROFN Territory”) within ten (10) days of receipt of such approval. Parent Parties hereby grant Seller and any Affiliates designated by Seller for such purpose (together, “Chiesi”) a right of first negotiation to grant a non-negotiate exclusive license rights to its interest commercialize any and all Lixivaptan Products for the Approved Indication in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described ROFN Territory identified in Section 11.4(b)(iii)an Initial Notice, then it shall first notify GSK and GSK Bio Chiesi must provide Parent with written notice of its exercise of such desire in writing, describing in reasonable detail the scope right of the license it is interested in granting to first negotiation (a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have within thirty (30) days from the receipt of the date on which it receives an Initial Notice; provided, however, that if Chiesi does not provide Parent with a ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of within such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia Section 5.2 shall negotiate exclusively in be void and of no further force and effect with respect to the Lixivaptan Product Approved Indication for the ROFN Territory. During the applicable ROFN Term, Chiesi and Parent will promptly and diligently, on an exclusive and good faith with GSK or GSK Biobasis, negotiate commercially reasonable terms for a period not an exclusive commercial agreement for the Lixivaptan Product Approved Indication in the ROFN Territory. Prior to exceed six (6) months from GSK’s or GSK Bio’s receipt the expiration of the applicable ROFN Notice Term, and subject to the terms of Section 5.2, Parent, directly or indirectly, including through its Affiliates and their respective Representatives, will not negotiate or enter into any commercialization or similar agreement with any third party with respect to any Lixivaptan Product for the ROFN Territory. If Chiesi does not timely deliver a ROFN Notice, Parent may negotiate and enter into definitive agreements with a third party (the “Negotiation PeriodThird Party Partner”), and Chiesi will have no further rights with respect to the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement Lixivaptan Product Approved Indication for the exclusive license by the end ROFN Territory, but shall retain a right of the Negotiation Period, then Liquidia shall be free to negotiate first negotiation with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license respect to any Third Party; provided, other Lixivaptan Product indication except to the extent that if Liquidia grants such non-exclusive license to a Third Party within nine (9the definitive agreement(s) months after the expiration of Negotiation Period, then the terms of with such Third Party license shall be no less favorable Partner obligate Parent to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a provide such Third Party Partner with a right of first negotiation, right of first refusal or similar rights in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-Howsuch ROFN Territory with respect to any additional Approved Indication, as the in which case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in refusal of Chiesi pursuant to this Section 4.3 5.1 and Section 5.2 shall only apply be subordinated in the field all respects to such right of prescription pharmaceutical productsfirst negotiation, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions right of this agreement as indicated by “[***]” and first refusal or similar rights of such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesThird Party Partner.
Appears in 1 contract
Sources: Stock Purchase Agreement (Centessa Pharmaceuticals LTD)
Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option PeriodCypress shall be permitted, Liquidia desires subject to grant a non-exclusive license this Section 2.4, to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii)develop, then it shall first notify GSK and GSK Bio of such desire in writingmake, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, salesell, offering offer for sale and import any Cypress Analogs, but not any Cypress Formulations, for any indication and this Agreement shall not include any rights with respect to Cypress Compounds or importation of products in any Information or Patents that pertain to the applicable field Cypress Compounds. Beginning upon the Effective Date and ending [...***...] (i.e. a field outside vaccines applications and/or the Inhaled Field"Exclusive Period"). GSK or GSK Bio , Forest shall have thirty (30) days from a first right to negotiate with Cypress to obtain a license to further develop and commercialize Cypress Compounds for all indications to the receipt extent Forest has not exercised the Option with respect to such Cypress Compounds. In the event Cypress desires to enter into a license arrangement for further development or commercialization of the ROFN Notice any Cypress Analog in any indication or plans to inform Liquidia further develop or commercialize any Cypress Analog itself, before entering into discussions with any Third Party with respect to such license or commencing such activities itself, Cypress will notify Forest in writing of its election desire. Forest may then elect, by providing written notice to negotiate the terms of such exclusive licenseCypress, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in enter into good faith negotiations with GSK or GSK Bio, Cypress with respect to such license for a period of 90 days following notice to Forest. In addition, Forest may provide written notice to Cypress at any time of its desire to negotiate a license arrangement for further development or commercialization of any Cypress Compound in any indication for a period of 90 days following notice to Cypress. If Cypress and Forest do not enter into an agreement with respect to exceed six such license during such 90 day period (6) months from GSK’s or GSK Bio’s receipt of such longer period agreed to in writing by the ROFN Notice (the “Negotiation Period”parties), the terms Cypress will be under which Liquidia no further obligation to negotiate a license with respect to such Cypress Compound, and, if such Cypress Compound is a Cypress Analog, Cypress will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to further develop and commercialize, or to negotiate and enter into an agreement with any Third Party with regard to further development and commercialization of, such Cypress Analog in any indication on any terms, subject to the last sentence of this Section 2.4(e). In addition, in the event a Cypress Analog is commercialized by Cypress or a sublicensee during the Exclusive Period, Cypress shall pay to Forest, a royalty of [...***...] on net sales of such Cypress Analog by Cypress or any Third Party to whom Cypress grants a license to such Cypress Analog; provided that such royalty rate may be reduced by written agreement of Cypress and Forest after good faith negotiations to account for a non-exclusive license within the same applicable field any royalty payments that was the subject of negotiations with GSK Cypress or GSK Bio, and to grant such non-exclusive license its sublicensees must make to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested Parties with respect to portions of this agreement as indicated by “such Cypress Analog. Such royalty shall be payable for the Exclusive Period, but in any event, the payment term shall not be less than [...***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines....
Appears in 1 contract
Sources: License and Collaboration Agreement (Cypress Bioscience Inc)
Right of First Negotiation. If at any time during the Inhaled Option Period and/or Vaccines Option Periodterm of this Agreement SCOLR proposes or intends to enter into any Additional License Opportunity with any Third Party, Liquidia desires to grant a non-exclusive license to its or if SCOLR receives any proposal or indication of interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to from a Third Party with respect to any Additional License Opportunity that SCOLR intends to pursue (an “ALO”), SCOLR shall provide written notice to Wyeth of such proposal or intent, along with reasonable details regarding such Additional License Opportunity (such notice from whom Liquidia has received SCOLR to Wyeth referred to as a term sheet or letter of intent (the “ROFN RFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive ). SCOLR hereby grants to Wyeth a right of first negotiation with respect to obtain each ALO. With respect to each ALO, during the period of [***] from the date of the relevant RFN Notice, SCOLR shall provide to Wyeth all information reasonably requested by Wyeth with respect to such ALO and Wyeth shall inform SCOLR whether Wyeth desires to negotiate an exclusiveagreement between SCOLR and Wyeth relating to such ALO. If Wyeth notifies SCOLR that it desires to negotiate an agreement between SCOLR and Wyeth relating to an ALO, worldwideSCOLR and Wyeth shall in good faith negotiate transaction terms and conditions and an agreement relating to the relevant Additional License Opportunity during the [***] period (or such longer period as may be agreed to by Wyeth and SCOLR) following the date of the notice by Wyeth referred to in clause (a) or (b) above, sublicensable license and during such period SCOLR and its directors, officers, representatives and agents shall discontinue all, and shall not initiate, encourage or engage in any, discussions with any Third Party with respect to Liquidia’s interest such Additional License Opportunity. If Wyeth and SCOLR do not execute an agreement with respect to such Additional License Opportunity despite their good faith efforts to do so in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation period of products time referred to in the applicable field (i.e. a field outside vaccines applications and/or preceding sentence, SCOLR shall be free to enter into an agreement, within [***] after the Inhaled Field)discontinuation of negotiations between SCOLR and Wyeth, for such Additional License Opportunity with one or more Third Parties on terms no less favorable to SCOLR than the terms last offered by SCOLR to Wyeth. GSK In order to keep Wyeth fully informed of potential Additional License Opportunities, SCOLR shall notify Wyeth promptly after becoming aware of any invention, development, license or GSK Bio acquisition that could be the subject of an Additional License Opportunity. In addition to the foregoing, from time to time, SCOLR shall have thirty (30) days from disclose any new technology relating to the receipt modification of the ROFN Notice to inform Liquidia duration of the activity or effectiveness of active pharmaceutical ingredients suitable for use with any product containing ibuprofen or any enantiomer or salt thereof, either alone or in writing combination with one or more of its election to the active ingredients, that SCOLR Controls and, if requested by Wyeth, negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of Wyeth the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested rights with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesthereto.
Appears in 1 contract
Sources: Development and License Agreement (SCOLR Pharma, Inc.)
Right of First Negotiation. If during In the Inhaled Option Period and/or Vaccines Option Periodevent that Phytera seeks a research, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How development or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to commercialization collaboration with a Third Party relating to the First Right Pre-Existing Antifungal Programs or a Third Party commences discussions with Phytera which Phytera intends to seriously consider in connection with Compounds resulting from whom Liquidia has received the First Right Pre-Existing Antifungal Programs, Phytera hereby grants to Lilly a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to (i) fund, in whole or in part, any research development, or commercialization collaboration or program ("Relevant Program") to be undertaken by Phytera with a Third Party with respect to a First Right Pre-Existing Antifungal Program Compound and (ii) obtain an exclusive, worldwide, sublicensable certain license rights to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights that results from such Relevant Program. This right shall be effective during the Research Term and shall operate as follows:
(which may include Liquidia Technologya) then controlled Phytera shall promptly send to Lilly a reasonably detailed written notification of any Relevant Program contemplated by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field Phytera using a First Right Pre-Existing Antifungal Program Compound;
(i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio b) Lilly shall have respond to Phytera within thirty (30) days from the of its receipt of such notification indicating its interest in funding, in whole or in part, the ROFN Notice Relevant Program and in obtaining rights to inform Liquidia any intellectual property resulting therefrom.
(c) For a period of up to sixty (60) days after Phytera receives notice of Lilly's interest in writing funding, in whole or in part, the Relevant Program and obtaining license rights to any intellectual property resulting therefrom, the Parties shall negotiate in good faith a reasonable agreement based upon the anticipated contributions of its election the Parties to negotiate the terms of Relevant Program and any products that result from such exclusive licenseRelevant Program. If, after good faith negotiations, an agreement cannot be reached between Lilly and another Phytera on the Relevant Program, Phytera shall be free to pursue such Relevant Program and commercialize any products that result from such Relevant Program, either independently or with one or more Third Parties.
(d) In the event that Lilly (i) fails to respond to Phytera within thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt notification by Phytera of the ROFN Notice contemplated Relevant Program, or (the “Negotiation Period”)ii) indicates that it is not interested in funding such Relevant Program and obtaining rights to any intellectual property resulting therefrom, the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia Phytera shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, pursue such Relevant Program and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means commercialize any products that cause a biological effect in humansresult from such Relevant Program, including, for example, vaccines, monoclonal antibodies and cytokineseither independently or with one or more Third Parties.
Appears in 1 contract
Sources: Research Agreement (Phytera Inc)
Right of First Negotiation. If during During the Inhaled Option Period and/or Vaccines Option PeriodTerm, Liquidia desires Idera hereby grants to grant Vivelix a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwidesublicensable license, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-HowDevelop, as applicablemake, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having have made, use, register, sell, have sold, offer for sale, offering for sale Commercialize, import and export any compound (other than Compounds) Controlled by Idera during the Term that has activity (as evidenced in preclinical models or importation of products in clinical development) in the applicable field (i.e. of inflammatory bowel disease and any and all intellectual property rights Controlled by Idera at any time covering the foregoing, and for which Idera has undertaken an active program to seek a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio partner for such field; provided, however, that Vivelix shall have thirty no such right with respect to any compound that has activity in the field of inflammatory bowel disease but for which Idera believes, in its good faith judgment based on data, inflammatory bowel disease will not be a lead indication. Idera will notify Vivelix in writing when any such compound is available for license and send to Vivelix all Data Controlled by Idera regarding such compound, which will be Confidential Information of Idera and subject to the confidentiality obligations set forth in Article 5. If Vivelix provides to Idera, within forty-five (3045) days from the after receipt of such data, a notice that includes the terms on which Vivelix would like to obtain such license under such intellectual property rights to such compound in the field of inflammatory bowel disease or the GI Field or, if agreed to by Idera any broader field, as determined by Vivelix in such notice (the “Chosen Disease Field”), Idera will negotiate in good faith exclusively with Vivelix for a period of ninety (90) days thereafter (or longer if such period is extended upon mutual agreement of the Parties) (the “ROFN Notice to inform Liquidia in writing of its election to negotiate End Date”) the terms of a definitive license agreement with respect to such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for compound in the Chosen Disease Field. If the Parties do not agree on the terms of a definitive license agreement with respect to such exclusive license. If GSK or GSK Bio delivers compound during such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day time period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not Idera will be permitted to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant license such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license compounds to a Third Party within nine licensee, provided that prior to the date that is one (91) months year after the expiration of Negotiation PeriodROFN End Date, then Idera will not be permitted to grant a license to such compound in the terms of such Chosen Disease Field to a Third Party license shall be no on terms that are less favorable to Liquidia Idera when taken as a whole than the terms last proposed offered by GSK or GSK Bio Vivelix. For purposes of the immediately preceding sentence, if Idera has chosen to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party a license to such compound in a particular proposed one or more fields that together are more broad than the Chosen Disease Field, such broader field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and considered an element of such license that is more favorable to Idera. If Idera does not subject to this Section 4.3 as to the particular field proposed to GSK. Furtherexecute an agreement with a Third Party licensee during such one (1)-year period, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the Vivelix’s right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject above will again apply with respect to Section 4.4 belowsuch compound if since the date on which Idera last sent to Vivelix all Data Controlled by Idera regarding such compound, Liquidia shall be free Idera has generated or obtained additional, material data with regard to grant non-exclusive licenses to such compound and its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply use in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesinflammatory bowel disease.
Appears in 1 contract
Right of First Negotiation. If during (a) If, following the Inhaled Option Period and/or Vaccines Option PeriodEffective Date, Liquidia desires to grant Alfacell determines that a particular Modified Targeted Ranpirnase compound demonstrates activity across one or more tumor cell types and has commercial viability (and such determination is reasonably supported by reasonable non-exclusive license to its interest clinical or pre-clinical data in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iiirespect of such cell type(s)), then it shall first notify GSK and GSK Bio Alfacell shall, prior to instituting any Phase III development program in respect thereof, provide Par with a one time written notice of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to information that Alfacell possesses or that Alfacell has a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive contractual right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party to obtain, subject to any corresponding contractual obligation, including copies of such data, and an estimate of the cost for developing and obtaining regulatory approval therefor, that is reasonably required by Par to determine whether or not to enter into negotiations for a non-license agreement with Alfacell with respect to such Modified Targeted Ranpirnase. The delivery of such notice shall automatically grant to Par an exclusive license within option (the same applicable field that was the subject of negotiations “Option”) to enter into an agreement with GSK or GSK Bio, and to grant such non-Alfacell for an exclusive license to permit Par to market, sell and have sold such Modified Targeted Ranpirnase in respect of the applicable indications (the “New License Agreement”). Par shall determine and notify Alfacell of its determination in writing, as soon as practicable, and in any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months event no more than *** after the expiration of Negotiation Period, then the terms grant of such Third Party license shall be no less favorable Option by Alfacell, to Liquidia than (i) exercise the terms last proposed Option by GSK or GSK Bio delivery of written notice to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date Alfacell of the ROFN Notice, and all its exercise of such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basisOption, or biological products (including biosimilar productsii) at any timereject the Option. The exercise, and the right or determination not to exercise, by Par of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription its rights under Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted information omitted and filed separately with the Securities and Exchange Commission Commission. Asterisks denote such omission. this Section 4.5(a) in respect of any granted Option shall not affect its rights in respect of any other Modified Targeted Ranpirnase compound that was not subject to such Option. Any data or other information provided by Alfacell to Par pursuant to Rule 24b-2 this Section 4.5(a) shall be deemed and treated as Confidential Information in accordance with and subject to Section 8.1. If Par fails to exercise its Option within such ***, or if Par rejects its Option, or if the Parties do not execute a New License Agreement despite their good faith efforts during the *** described in subsection (b) below, then within ten (10) business days after such failure, rejection or absence of execution (as applicable), Par shall return to Alfacell all documentation containing Confidential Information of Alfacell that was received by Par pursuant to this Section 4.5(a).
(b) If Par exercises its Option, the Parties shall, during the *** from the date of exercise of the Securities Exchange Act of 1934Option, as amendednegotiate exclusively a New License Agreement with one another in good faith. basisIf, following such ***, the Parties have not executed the New License Agreement despite their good faith efforts, Alfacell may, but shall not be obligated to, offer such license for Modified Targeted Ranpirnase for the applicable indication(s) to a Third Party. If Par rejects the Option, or vaccine or biological products does not inform Alfacell of its exercise of the Option within the *** after the grant of such Option by Alfacell, (including biosimilar products). For i) Alfacell may, but shall not be obligated to, negotiate and enter into a license agreement with a Third Party, and (ii) thereafter the particular Modified Targeted Ranpirnase that had been subject to such Option shall be deemed to no longer be a “Competing Product” for purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesAgreement.
Appears in 1 contract
Sources: License Agreement (Alfacell Corp)
Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”a) and GSK and/or GSK Bio thereafter Licensee shall have the exclusive a right of first negotiation to obtain an exclusive, worldwide, sublicensable license expand the Field to Liquidia’s interest include any new Indications for License Products in accordance with this Section 2.1.6(a) (such rights are referred to herein as the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field“Field Expansion Rights”). GSK or GSK Bio If Licensee desires to license the Licensed Product for any Indications outside of the Field, it shall have notify Licensor in writing and the Parties shall proceed to negotiate in good faith pursuant to Section 2.1.6(c) below. Licensor shall not offer to license the Licensed Product for any Indication outside of the Field to a Third Party without first offering such right to Licensee and providing Licensee a thirty (30) days from day evaluation period.
(b) If at any time Licensor desires to license the receipt Licensed Products in the Field in any country outside of the ROFN Notice Territory to inform Liquidia in writing any Third Party, it shall first offer such rights to Licensee by providing written notice of its election bona fide intent to negotiate the terms do so and Licensee shall have a period of such exclusive license, and another thirty (30) days to submit assess whether Licensee desires to Liquidia an initial proposal for expand the terms Territory to include such country (“Territory Expansion Rights”).
(c) If Licensee desires to exercise such Field Expansion Rights or Territory Expansion Rights it shall notify Licensor in writing prior to the expiration of such exclusive license. If GSK or GSK Bio delivers such notice during the first applicable thirty (30) day evaluation period and submits the initial proposal within the second thirty (30) day period, Liquidia Parties shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six of ninety (690) months from GSK’s or GSK Bio’s receipt of the ROFN Notice days thereafter (the “Negotiation Period”)) to amend this Agreement as appropriate on reasonable market terms to include such expanded rights. If, the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end expiration of the Negotiation Period, the Parties have not Agreed in principle to the material terms regarding the applicable expansion rights, then Liquidia shall be free to negotiate with at any Third Party for a nontime during the one-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine hundred eighty (9180) months after day period following the expiration of the Negotiation Period, then the terms of such Third Licensor or its Affiliate may consummate a Third-Party license shall be no less or sale, as applicable, on terms that are more favorable to Liquidia the Licensor or its Affiliate than the terms last proposed offered by GSK Licensee during the negotiations. If such Third-Party license or GSK Bio to Liquidia. Notwithstanding anything to the contrarysale is not consummated within such one-hundred eighty (180) day period, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date terms and conditions of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as 2.1.6 will again apply and Licensor shall not and shall cause its Affiliates not to the particular field proposed to GSK. Further, each time Liquidia desires to grant a nonenter into any Third-exclusive Party sale or license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately the applicable rights without giving Licensee another opportunity to negotiation the applicable expansion rights in accordance with the Securities terms and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products)conditions hereof. For purposes of this Section 4.3Section, “biological productsAgreed” means as memorialized in a fully executed term sheet setting forth the material terms as non-binding, and including certain customary binding provisions (such as those regarding confidentiality, expenses, and a reasonable exclusivity period). Licensor shall not and shall cause its Affiliates not to sell or license in any products that cause a biological effect in humans, including, manner to any Third Party any Licensed Product for example, vaccines, monoclonal antibodies and cytokinessuch Indication or country prior to the compliance with the foregoing.
Appears in 1 contract
Sources: Exclusive Sublicense Agreement (Hoth Therapeutics, Inc.)
Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter Licensor shall have the an exclusive right of first negotiation during the ROFN Period to obtain acquire development and commercial rights to AN659 Products as provided in this Section 2.
a. Licensee will provide prompt written notice to Licensor (i) of the first public announcement by Licensee of the top-line results for [***]Phase 2 Clinical Trials for an exclusive, worldwide, sublicensable license to Liquidia’s interest AN659 Product in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicableAdditional AN659 Field, and any other intellectual property (ii) on the date Licensee determines it wishes or intends to commence discussions or negotiations to license or otherwise partner the development and commercial rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products to AN659 Products in the applicable field Additional AN659 Field (i.e. in each case, a field outside vaccines applications and/or the Inhaled Field“ROFN Notice”). GSK or GSK Bio shall Licensor will have thirty a period of [***] days (30the “ROFN Exercise Period”) days from the receipt date of the applicable ROFN Notice to inform Liquidia notify the Licensee in writing that Licensor would like to exercise its right of its election to negotiate the terms of such exclusive licensefirst negotiation (a “ROFN Exercise Notice”).
b. If Licensor timely provides a ROFN Exercise Notice, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Biothen, for a period not of up to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice [***]days following such election by Licensor (the “Negotiation Period”), the parties shall exclusively negotiate in good faith regarding commercially reasonable terms under upon which Liquidia will grant such exclusive license the rights to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for all AN659 Products in the exclusive license Additional AN659 Field may be acquired by Licensor from Licensee; provided, however, that, if at the end of the Negotiation PeriodPeriod the Parties have not reached mutual agreement with regard to such terms as evidenced by a written definitive agreement, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject period of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with months beginning on the Securities and Exchange Commission pursuant to Rule 24b-2 expiration of the Securities Exchange Act Negotiation Period, Licensee may pursue negotiations regarding a transaction with Third Parties with respect to rights to AN659 Products on terms [***]to the Third Party than the terms to Licensor set forth in the best offer from Licensor during the Negotiation Period; provided further, if Licensee has not signed a definitive agreement by the expiration of 1934such [***]month period, then Licensee shall again be subject to the provisions of this Section 2 until the expiration of the ROFN Period. Neither Party shall be obligated to enter into any definitive agreement except on such terms as amendedare acceptable to such party in its sole and absolute discretion.
c. If Licensor does not provide a timely ROFN Exercise Notice to Licensee, then for a period of [***]months beginning on the expiration of the ROFN Exercise Period, Licensee may pursue negotiations regarding a transaction with Third Parties with respect to rights to AN659 Products; provided, however, if Licensee has not signed a definitive agreement by the expiration of such [***]month period, then Licensee shall again be subject to the provisions of this Section 2 until the expiration of the ROFN Period.
d. During any Negotiation Period, Licensee shall promptly provide Licensor access to development, regulatory, commercialization and other material information and data for the AN659 Products as requested by Licensor in good faith.
e. Nothing in this Section 2 shall prevent Licensee from negotiating or completing any transaction for the sale of all or substantially all of the business or assets of Licensee, whether by merger, sale of stock, sale of assets or otherwise. basisThe obligations under this Section 2 shall survive a Change in Control of Licensee, or vaccine or biological products (including biosimilar products)and shall be binding on any Third Party acquiror of the Licensee following such Change in Control. For A Change in Control for purposes of this Section 4.3, “biological products” 2(e) means any products that cause of the following transactions consummated by Licensee: (a) a biological effect sale or other disposition of all or substantially all of the assets of Licensee to a Third Party; (b) any consolidation, merger or reorganization of Licensee in humanswhich the holders of the voting securities of Licensee outstanding immediately prior to consummation of such consolidation, includingmerger or reorganization cease to own, for exampledirectly or indirectly, vaccinesat least [***]% of the combined voting power of the surviving entity (or, monoclonal antibodies if the surviving entity is a wholly owned subsidiary, its parent) immediately after consummation such consolidation, merger or reorganization; or (c) any transaction or series of related transactions in which a Third Party or group of Third Parties acting in concert acquires more than [***]% of the voting securities of Licensee.
f. During the ROFN Period, notwithstanding anything to the contrary in this Section 2, Licensee shall provide prompt written notice to Licensor if Licensee wishes or intends to commence discussions to license or otherwise partner the development and cytokinescommercial rights to any AN659 Product in the Initial AN659 Field.
Appears in 1 contract
Sources: License Agreement (Longboard Pharmaceuticals, Inc.)
Right of First Negotiation. If In the event that GPC Biotech Controls any Derivative Compound during the Inhaled term of this Agreement for which there is clinical data demonstrating efficacy, GPC Biotech shall provide to Licensee written notice thereof (each, a “Compound Option Period and/or Vaccines Option Period, Liquidia desires to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iiiNotice”), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter Licensee shall have the an exclusive option and right of first negotiation to obtain an exclusive, worldwide, sublicensable license rights to Liquidia’s interest Commercialize such Derivative Compound in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products Licensee Territory in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have Field by giving written notice to GPC Biotech within thirty (30) days from the after Licensee’s receipt of the ROFN Notice such Compound Option Notice. If Licensee fails to inform Liquidia provide timely written notice of its desire to Commercialize such Derivative Compound, or notifies GPC Biotech in writing of its election that Licensee does not desire to acquire such rights and obligations, then GPC Biotech shall have the right to enter into an agreement with a Third Party to Commercialize and otherwise Exploit such Derivative Compound, without any further obligation to negotiate the terms with Licensee, or provide to Licensee a right of such exclusive licensenegotiation, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive licensewith respect thereto. If GSK or GSK Bio delivers such Licensee provides timely written notice during of interest, then the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia Parties shall negotiate exclusively in good faith with GSK or GSK Biorespect to the foregoing, but neither Party shall have any obligation to enter into any agreement unless they are able to agree on mutually acceptable terms and conditions at such time. In the event the Parties are unable to conclude such an agreement within [...***...] after receipt by GPC Biotech of Licensee’s written notice of interest, Licensee shall provide to GPC Biotech a detailed written summary of the terms on which Licensee would have been prepared to conclude such agreement. If Licensee indicates in writing at such time to GPC Biotech that Licensee desires to continue negotiations with GPC Biotech, the Parties shall continue to negotiate in good faith, provided that GPC Biotech shall be free from and after the end of such [...***...] negotiation period to negotiate and enter into agreements with Third Parties; provided, further that, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by [...***...] after the end of the Negotiation Periodsuch [...***...] negotiation period, then Liquidia GPC Biotech shall be free to negotiate with not enter into any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to agreement on any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia GPC Biotech, when taken as a whole, than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms those set forth above. Subject in Licensee’s written offer to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesGPC Biotech.
Appears in 1 contract
Sources: Co Development and License Agreement (Pharmion Corp)
Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires to grant SIBIA hereby grants Lilly a non-exclusive license to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain enter into an exclusiveexclusive license arrangement with SIBIA with respect to each Pre-Existing Compound ("Right of First Negotiation") whereby SIBIA agrees that it will neither negotiate nor enter into an arrangement involving a particular Pre-Existing Compound in which SIBIA would license/sublicense or otherwise commercialize such Pre-Existing Compounds and/or products derived therefrom with a Third Party (the "Third Party Commercialization Arrangement") prior to the expiration of the Lilly Negotiation Period (defined below). To ensure that Lilly has adequate time to consider whether it should exercise its Right of First Negotiation with respect to a particular Pre-Existing Compound, worldwideSIBIA hereby agrees that prior to negotiating or entering into any Third Party Commercialization Arrangement regarding a particular Pre-Existing Compound, sublicensable license SIBIA shall provide Lilly with written notification of its intent to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-Howenter into such an arrangement including, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia without limitation a summary report of all relevant information that are necessary or would be reasonably useful for to a potential licensee of the makingPre-Existing Compound at issue so as to assess the business opportunity at issue. Upon receipt of such notice, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio Lilly shall have thirty forty-five (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (3045) days to submit provide SIBIA with written notification exercising its Right of First Negotiation. Lilly's Right of First Negotiation under this Section 5.7(a) shall expire and have no legal effect with respect to Liquidia an initial proposal for the terms particular Pre-Existing Compound at issue in the event that: (i) Lilly does not provide SIBIA with its written notice to exercise its Right of such exclusive license. If GSK or GSK Bio delivers such notice during First Negotiation within the first thirty prescribed forty-five (3045) day period as described above; (ii) SIBIA and submits Lilly enter into mutually acceptable written agreement regarding such matter; or (iii) the initial proposal within lapse of ninety (90) days or such other term as is mutually agreed upon in writing by the second thirty Parties from the date upon which SIBIA receives written notice from Lilly exercising its Right of First Negotiation (30collectively, the "Lilly Negotiation Period"). For avoidance of any doubt, this Section 5.7(a) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period merely obligates SIBIA to abide by the notice provisions set forth herein and not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to enter into a Third Party within nine Commercialization Arrangement until such time that the Lilly Negotiation Period has expired (9) months after it is understood that the expiration of Negotiation Period, then ultimate decision regarding the terms of such Third Party license shall be no less favorable appropriate party to Liquidia than the terms last proposed by GSK or GSK Bio sublicense rights related to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration KnowPre-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation PeriodExisting Compound(s) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar productscompletely within SIBIA's sole discretion). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokines.
Appears in 1 contract
Right of First Negotiation. If during Licensor shall not enter into an agreement with any Third Party to license the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires Licensed IP with regard to grant a non-exclusive license to its interest the Development and Commercialization of Licensed Products in the Joint Inhaled Collaboration Know-How Territory for any Indication or Joint Vaccines Collaboration Know-How as described formulation not included in Section 11.4(b)(iii)the Field, then it shall unless Licensor has first notify GSK delivered to Avenue written notice offering Avenue to negotiate with Licensor the terms and GSK Bio conditions of an amendment to this Agreement to include such desire in writing, describing in reasonable detail the scope new Indication or formulation outside of the license Field, which notice shall identify the specific Indication or formulation for which it is interested in granting would like to enter into such negotiation (Avenue’s such right to negotiate herein referred to as “Right of First Negotiation;” such notice, a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice;” such new indication or formulation, the “Identified New License”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field)). GSK or GSK Bio Avenue shall have respond to Licensor within thirty (30) calendar days from the following its receipt of the ROFN Notice to inform Liquidia indicate its interest in writing exercising its Right of First Negotiation (an “Exercise Notice”). If Avenue causes Licensor to receive such an Exercise Notice exercising its election to negotiate the terms Right of First Negotiation within such exclusive license, and another thirty (30) calendar day period, then, for a period of up to ninety (90) calendar days to submit to Liquidia an initial proposal for the terms following Licensor’s receipt of such exclusive licenseExercise Notice, the Parties shall use Commercially Reasonable Efforts to negotiate in good faith a reasonable agreement granting Avenue rights to Develop and Commercialize Licensed Products in the Identified New License on terms mutually acceptable to both Parties. If GSK or GSK Bio delivers such notice during In the first event that: (a) Avenue does not provide an Exercise Notice within thirty (30) day period and submits calendar days of receipt of the initial proposal ROFN Notice; or (b) Avenue provides an Exercise Notice to Licensor within the second such thirty (30) calendar day period, Liquidia but the Parties do not execute a definitive agreement granting Avenue rights to Develop and Commercialize Licensed Products in the Identified New License within the ninety (90) day negotiation period mentioned above, Avenue shall negotiate exclusively in good faith with GSK or GSK Bionot have any further rights, for a period and Licensor shall not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”)have any further obligations, the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio this Section 2.5 and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia Licensor shall be free to negotiate enter into negotiations and/or execute a definitive agreement with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of granting such Third Party license shall be no less favorable the right to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, Develop and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK Commercialize Licensed Products in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesIdentified New License.
Appears in 1 contract
Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires 14.1 The Parties acknowledge their mutual desire to grant explore a non-exclusive license to its interest broader collaboration whereby Glycyx would develop and market CKD GI Products in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described Glycyx Territory. Therefore, in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire addition to the exclusive rights granted to CKD in writing, describing in reasonable detail the scope respect of the license it is interested in granting Product under Clause 2 CKD hereby grants to Glycyx a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation with respect to obtain an exclusive, worldwide, sublicensable license rights to Liquidia’s interest develop and exploit CKD GI Products in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for Glycyx Territory.
14.2 During the making, having made, use, sale, offering for sale or importation period of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days [*] years from the date hereof CKD shall provide written notification to Glycyx of any opportunity in respect of a CKD GI Product (such notice, a “Product Notice”), which Product Notice shall be served promptly on any CKD GI Product being available for licensing outside the Territory. Such Product Notice shall contain a description in reasonable detail of the CKD GI Product(s) and such other information as may reasonably be required to enable Glycyx to assess the CKD GI Product opportunity. Upon request by Glycyx within [*] days after receipt of such Product Notice (the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms date of such exclusive licensereceipt the “Notice Date” and such period the “Notice Period”), and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia Parties shall negotiate exclusively in good faith with GSK or GSK Bio, for a period towards an agreement granting to Glycyx exclusive rights in respect of the CKD GI Product in the Glycyx Territory. If Glycyx chooses not to exceed six (6) months from GSK’s or GSK Bio’s receipt request such negotiations, it shall so notify CKD promptly before the expiry of the ROFN Notice Period and if Glycyx makes no communication within the Notice Period, it shall be deemed to have not effected a request. If notwithstanding good faith negotiations the Parties do not enter into a definitive agreement within [*] days of the Notice Date (the “Negotiation Period”), CKD may proceed to grant rights or licenses to Third Parties with respect to all or a part of the CKD GI Product(s) opportunity offered to Glycyx provided that CKD shall not enter into a transaction in respect of the CKD GI Product(s) opportunity in the Glycyx Territory proposed by CKD to Glycyx with a Third Party on terms under which Liquidia will grant such exclusive license which, assessed as a whole, are materially less favourable to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for CKD than those proposed by Glycyx in the exclusive license by course of the end of good faith negotiations during the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject .
14.3 The only obligations of negotiations with GSK or GSK BioCKD and Glycyx under this Clause 14 are as expressly stated therein, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be there are no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything further implied obligations relating to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSKmatters contemplated therein. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription [*] Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted requested; certain information omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesSEC.
Appears in 1 contract
Right of First Negotiation. (a) If during after the Inhaled Option Period and/or Vaccines Option PeriodEffective Date PTI develops, Liquidia desires has developed or otherwise comes to grant a non-exclusive license to its interest in the Joint Inhaled Collaboration Control Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii)Patent Rights outside of the Collaboration, then it shall first notify GSK and GSK Bio PTI initiates the use or practice of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, Patent Rights as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt part of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of Collaboration, or either Party otherwise determines that such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-HowPatent Rights are necessary or useful to Biogen Idec to Develop one or more Licensed Products that Biogen Idec is actively Developing or Commercializing (“Additional Intellectual Property”), as then PTI will promptly notify Biogen Idec in writing of such Additional Intellectual Property, and Biogen Idec will have [***] from its receipt of such notice to determine whether it wishes to enter into negotiations with PTI for a license under such Additional Intellectual Property to research, Develop, manufacture, use, sell and import such applicable Licensed Product(s) in the case Field and for no other purpose. If Biogen Idec notifies PTI in writing that it would like to enter into negotiations for such license, the Parties will negotiate in good faith for a period of up to [***] to reach agreement on a license agreement for such Additional Intellectual Property. If the Parties are able to enter into such a license agreement, then the Parties’ respective rights and obligations with regard to such Additional Intellectual Property will be set forth in such agreement. If (i) Biogen Idec informs PTI that it does not wish to enter into negotiations with PTI for an exclusive license under such Additional Intellectual Property, (ii) Biogen Idec fails to provide such notice that it wishes to enter into negotiations with PTI for an exclusive license under such Additional Intellectual Property within the required [***] period, or (iii) Biogen Idec provides notice that it wishes to enter into negotiations with PTI for an exclusive license under such Additional Intellectual Property within the required [***] period, but the Parties fail to come to agreement on such a license agreement within the required [***] period then, in each case, PTI will have no further obligations to Biogen Idec with regard to the applicable Additional Intellectual Property; except that, PTI may benot license such Additional Intellectual Property to research, Develop, manufacture, use, sell and import the applicable Licensed Product(s) on terms that arises during are materially less favorable to PTI in the Inhaled Collaboration Term or Vaccine Collaboration Termaggregate than those offered by Biogen Idec in its final offer for a period of an additional [***].
(b) Notwithstanding the foregoing, as in the case may be, including after the date event of the ROFN Noticeacquisition of PTI, and all such Joint Inhaled Collaboration the Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How and Patent Rights of PTI that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not are subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to in Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration 7.6(a) will not include (i) any Know-How or Joint Vaccine Collaboration Know-How outside Patent Rights Controlled by the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by acquiring CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]” and such confidential portions have been deleted and filed separately with ”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Execution Version entity immediately prior to the Securities and Exchange Commission pursuant to Rule 24b-2 consummation of the Securities Exchange Act of 1934acquisition or (ii) any Know-How or Patent Rights that are developed or acquired by the acquiring entity following such acquisition, as amended. basisexcept for any such Know-How or Patent Rights that result from, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3are acquired in support of, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesthe Collaboration.
Appears in 1 contract
Sources: Collaborative Research, Development, Commercialization and License Agreement
Right of First Negotiation. If during CSL shall have a right of first refusal to the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires grant of any rights in the Field after the Effective Date to BioCryst Intellectual Property Rights in territories outside the Territory (each such proposed grant being a “New Opportunity”). When BioCryst is ready to grant rights to a non-exclusive license New Opportunity, BioCryst shall submit to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio CSL a reasonably detailed description of such desire New Opportunity, together with a financial proposal for the grant of rights to the New Opportunity. BioCryst shall promptly respond to all reasonable requests of CSL for additional information required in writing, describing in reasonable detail the scope connection with CSL's exercise of the license it is interested in granting to a Third Party right granted under this Section 2.8. CSL will have *** Business Days starting from whom Liquidia has received a term sheet or letter the date of intent receipt of BioCryst’s proposal (the “ROFN NoticeEvaluation Period”) to evaluate such proposal and GSK and/or GSK Bio thereafter to submit a counterproposal to BioCryst. In the event that CSL shall have submit a written counterproposal to BioCryst prior to the exclusive right expiration of first negotiation to obtain an exclusivethe Evaluation Period, worldwide, sublicensable license to Liquidia’s interest in then during the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (30) days *** Business Days period from the receipt date of the ROFN Notice submission of CSL’s counterproposal to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice BioCryst (the “Negotiation Period”), the Parties shall discuss in good faith the acceptable market terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license grant of rights to CSL in respect of the New Opportunity. During the Evaluation Period and the Negotiation Period (up to *** Business Days in the aggregate, which may be extended by mutual agreement) BioCryst shall not directly or indirectly propose, grant or negotiate with any third party any rights relating to the end relevant New Opportunity. To the extent that BioCryst and CSL shall not reach an agreement regarding the New Opportunity prior to the expiration of the Negotiation Period, then Liquidia BioCryst shall be free to negotiate and effect any transaction with any Third Party for a non-exclusive license within third party regarding the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesrelevant New Opportunity.
Appears in 1 contract
Right of First Negotiation. If during For a period of [***] from the Inhaled Option Period and/or Vaccines Option PeriodEffective Date, Liquidia desires to grant if Anacor completes a non-exclusive license to its interest Phase II Study on a product that contains a compound having the same mechanism of action as the Licensed Compound (other than the Licensed Product) claimed by Anacor Background Patents in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iiiLead Indication ("Competing Product"), then it Anacor shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the scope of the license it is interested in granting grant to Licensee a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusiveDevelop, worldwide, sublicensable license Manufacture and Commercialize such Competing Product at such time as the Phase II Data Set (as defined below) is completed. Anacor shall provide the Phase II Data Set to Liquidia’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, Licensee for its review and any other intellectual property rights consideration. Licensee shall provide written notice to Anacor within sixty (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field). GSK or GSK Bio shall have thirty (3060) days from the of receipt of the ROFN Notice to inform Liquidia in writing Phase II Data Set of its election decision either to enter into negotiations with Anacor for such Competing Product or to forego such negotiations. If Licensee elects to enter into such negotiations, then the Parties will negotiate regarding such license for a period of up to ninety (90) days, such period of time may be extended if agreed by the terms Parties. Following the earlier of the expiration of such exclusive license, and another thirty ninety (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (3090) day period and submits (or any agreed upon extended period) or the initial proposal within the second thirty (30) day perioddate Licensee notifies Anacor that it does not wish to proceed with such negotiations, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt of the ROFN Notice (the “Negotiation Period”), the terms under which Liquidia will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia Anacor shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, Parties and shall have no further obligations to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to Licensee under this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested 2.8 with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products)that Competing Product. For purposes of this Section 4.32.8, “biological products” "Phase II Data Set" means any products that cause a biological effect in humanspackage of preclinical and clinical data related to the Competing Product generated by or on behalf of Anacor, includingincluding without limitation, for exampleas available, vaccinesthe data and results of all phase I clinical studies, monoclonal antibodies Phase II Studies, and cytokinesall available toxicology and pharmacokinetic data. [***] THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
Appears in 1 contract
Sources: License, Development, and Commercialization Agreement (Anacor Pharmaceuticals Inc)
Right of First Negotiation. If during Fulcrum or any of its Affiliates intend to enter into any confidential discussions with a Third Party with respect to the Inhaled Option Period and/or Vaccines Option Periodlicense, Liquidia desires sale, assignment or other transfer or grant of rights (other than, in each case, the transfer or grant of solely subcontracting rights) to grant such Third Party to Research, Develop, or Commercialize any Licensed Compound or Licensed Product in the Field in the Fulcrum Territory, then, prior to entering into a non-exclusive license disclosure agreement with such Third Party, Fulcrum shall provide to its interest in Sanofi written notice of the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire in writing, describing in reasonable detail the proposed scope of the license it is interested in granting Research, Development or Commercialization rights that F▇▇▇▇▇▇ proposes to a grant to such Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall ). Thereafter, Sanofi will have an exclusive right, exercisable no later than [***] after receipt of any such ROFN Notice from Fulcrum, to notify Fulcrum in writing as to whether Sanofi desires to negotiate for such rights to Research, Develop or Commercialize the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidia’s interest Licensed Compounds or Licensed Products in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as applicable, and any other intellectual property rights Fulcrum Territory (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products in the applicable field (i.e. a field outside vaccines applications and/or the Inhaled Field“ROFN Exercise Notice”). GSK or GSK Bio shall If Sanofi provides a ROFN Exercise Notice to Fulcrum within such [***] period, then Sanofi will have thirty (30) days a one-time right for [***] from the receipt date of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in good faith with GSK or GSK Bio, for a period not to exceed six (6) months from GSK’s or GSK BioFulcrum’s receipt of the ROFN Notice (the “ROFN Negotiation Period”), ) to require the Parties to exclusively negotiate in good faith the terms under of a definitive agreement (or amendment to this Agreement) pursuant to which Liquidia will Fulcrum would grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for Sanofi the exclusive license by rights to Research, Develop or Commercialize the end of Licensed Compounds or Licensed Products in the Fulcrum Territory, and (b) upon Sanofi’s request during the ROFN Negotiation Period, (i) Fulcrum will provide Sanofi with all information and documentation reasonably requested by Sanofi in Fulcrum’s or its Affiliate’s possession and Control relating to the Licensed Compounds or Licensed Products in the Fulcrum Territory and (ii) afford Sanofi and its representatives reasonable access during normal business hours to Fulcrum’s personnel reasonably designated by Fulcrum to address Sanofi’s inquiries. Neither Party will have any obligation to enter into any agreement or amendment to this Agreement granting rights to Sanofi to Research, Develop or Commercialize the Licensed Compounds or Licensed Products in the Fulcrum Territory. If the ROFN Negotiation Period expires before the Parties have entered into an agreement or amendment to this Agreement with respect to Sanofi’s Research, Development or Commercialization of the Licensed Compounds or Licensed Products in the Fulcrum Territory, then Liquidia shall Fulcrum will have no further obligation to negotiate with Sanofi with respect to any grant of such rights to Sanofi and, for a period of [***], will be free to negotiate and enter into an agreement with any Third Party for with respect to a non-exclusive license within grant of rights to Research, Develop or Commercialize the same applicable field Licensed Compounds or Licensed Products in the Fulcrum Territory, provided that was (x) any transaction that is the subject of such negotiations and agreement with GSK one or GSK Bio, more Third Parties shall not exceed the scope of Development and to grant such non-Commercialization rights described in the applicable ROFN Notice; (y) Sanofi’s exclusive license negotiation rights under this Section 2.8 (Right of First Negotiation) shall remain in effect with respect to any Third Partynegotiations by Fulcrum in respect of the Licensed Compounds or Licensed Products for transactions of a different scope; provided, that and (z) if Liquidia grants such non-exclusive license Fulcrum or its Affiliates fail to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of enter into any such Third Party license shall be no less favorable to Liquidia than agreement during such [***] period, following expiration of such [***], Sanofi would again have the terms last proposed by GSK or GSK Bio to Liquidiaright of first negotiation for such rights in accordance with the provisions of this Section 2.8 (Right of First Negotiation). Notwithstanding anything to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described contrary in this Section 4.32.8 (Right of First Negotiation), either a Change of Control of Fulcrum or its Affiliates will not trigger Fulcrum’s obligation to the same Third Party or provide a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesROFN Notice.
Appears in 1 contract
Sources: Collaboration and License Agreement (Fulcrum Therapeutics, Inc.)
Right of First Negotiation. If during the Inhaled Option Period and/or Vaccines Option Period, Liquidia desires 14.1 The Parties acknowledge their mutual desire to grant explore a non-exclusive license to its interest broader collaboration whereby Glycyx would develop and market CKD GI Products in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How as described Glycyx Territory. Therefore, in Section 11.4(b)(iii), then it shall first notify GSK and GSK Bio of such desire addition to the exclusive rights granted to CKD in writing, describing in reasonable detail the scope respect of the license it is interested in granting Product under Clause 2 CKD hereby grants to Glycyx a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation with respect to obtain an exclusive, worldwide, sublicensable license rights to Liquidia’s interest develop and exploit CKD GI Products in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-HowGlycyx Territory.
14.2 During the period of [*] years from the date hereof CKD shall provide written notification to Glycyx of any opportunity in respect of a CKD GI Product (such notice, a “Product Notice”), which Product Notice shall be served promptly on any CKD GI Product being available for licensing outside the Territory. Such Product Notice shall contain a description in reasonable detail of the CKD GI Product(s) and such other information as applicablemay reasonably be required to enable Glycyx to assess the CKD GI Product opportunity. Upon request by Glycyx within [*] days after receipt of such Product Notice (the date of such receipt the “Notice Date” and such period the “Notice Period”), the Parties shall negotiate in good [*] Confidential treatment requested; certain information omitted and any other intellectual property filed separately with the SEC faith towards an agreement granting to Glycyx exclusive rights (which may include Liquidia Technology) then controlled by Liquidia that are necessary or reasonably useful for in respect of the making, having made, use, sale, offering for sale or importation of products CKD GI Product in the applicable field (i.e. a field outside vaccines applications and/or Glycyx Territory. If Glycyx chooses not to request such negotiations, it shall so notify CKD promptly before the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt expiry of the ROFN Notice Period and if Glycyx makes no communication within the Notice Period, it shall be deemed to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive licensehave not effected a request. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal within the second thirty (30) day period, Liquidia shall negotiate exclusively in notwithstanding good faith with GSK or GSK Bio, for negotiations the Parties do not enter into a period not to exceed six (6) months from GSK’s or GSK Bio’s receipt definitive agreement within [*] days of the ROFN Notice Date (the “Negotiation Period”), CKD may proceed to grant rights or licenses to Third Parties with respect to all or a part of the CKD GI Product(s) opportunity offered to Glycyx provided that CKD shall not enter into a transaction in respect of the CKD GI Product(s) opportunity in the Glycyx Territory proposed by CKD to Glycyx with a Third Party on terms under which Liquidia will grant such exclusive license which, assessed as a whole, are materially less favourable to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for CKD than those proposed by Glycyx in the exclusive license by course of the end of good faith negotiations during the Negotiation Period, then Liquidia shall be free to negotiate with any Third Party for a non-exclusive license within the same applicable field that was the subject .
14.3 The only obligations of negotiations with GSK or GSK BioCKD and Glycyx under this Clause 14 are as expressly stated therein, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the terms of such Third Party license shall be there are no less favorable to Liquidia than the terms last proposed by GSK or GSK Bio to Liquidia. Notwithstanding anything further implied obligations relating to the contrary, the licenses that Liquidia may grant to a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall be thereafter excluded from and not subject to this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humans, including, for example, vaccines, monoclonal antibodies and cytokinesmatters contemplated therein.
Appears in 1 contract
Right of First Negotiation. If If, during the Inhaled Option Period and/or Vaccines Option Periodterm of this Agreement, Liquidia (i) Neurogenetics desires to grant a non-exclusive license sublicense to any Person (other than any Affiliate of Neurogenetics) its interest commercialization rights under this Agreement in the Joint Inhaled Collaboration Know-How United States or Joint Vaccines Collaboration Know-How sublicense or otherwise transfer (except as described permitted under Section 11.10) all of its rights under this Agreement (including the Neurogenetics Technology) worldwide, or (ii) a Third Person initiates such discussions with Neurogenetics and Neurogenetics is interested in Section 11.4(b)(iiientertaining such discussions (both (i) and (ii) are collectively referred to as a “Business Opportunity”), then it shall first Neurogenetics will promptly notify GSK and GSK Bio Lilly in writing thereof, with such notice containing all reasonable available information necessary for a potential licensee or commercialization partner to evaluate the Business Opportunity, including proposed terms of such desire transaction; provided that in writing, describing in reasonable detail no event will Neurogenetics be required to disclose to Lilly the scope identity or confidential information of any Third Person. Within [***] days of Lilly’s receipt of the license it is interested written notice, Lilly will respond to Neurogenetics in granting to a Third Party from whom Liquidia has received a term sheet or letter of intent (the “ROFN Notice”) and GSK and/or GSK Bio thereafter shall have the exclusive right of first negotiation to obtain an exclusive, worldwide, sublicensable license to Liquidiawriting regarding Lilly’s interest in the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-HowBusiness Opportunity. If Lilly indicates interest in pursuing the Business Opportunity, as applicable, and any other intellectual property rights the Parties will negotiate in good faith to enter into a definitive agreement. If (which may include Liquidia Technologyi) then controlled by Liquidia that are necessary or reasonably useful for the making, having made, use, sale, offering for sale or importation of products Lilly indicates no interest in the applicable field (i.e. a field outside vaccines applications and/or Business Opportunity or does not respond to Neurogenetics with respect to the Inhaled Field). GSK or GSK Bio shall have thirty (30) days from the receipt of the ROFN Notice to inform Liquidia in writing of its election to negotiate the terms of such exclusive license, and another thirty (30) days to submit to Liquidia an initial proposal for the terms of such exclusive license. If GSK or GSK Bio delivers such notice during the first thirty (30) day period and submits the initial proposal applicable Business Opportunity within the second thirty (30) applicable [***] day period, Liquidia shall negotiate exclusively in or (ii) Lilly and Neurogenetics are unable, other than through lack of good faith with GSK or GSK Bioon the part of Neurogenetics, for to enter into a period not to exceed six (6) months from GSK’s or GSK Biodefinitive agreement within [***] days after Lilly’s receipt of the ROFN Notice (the “Negotiation Period”)Neurogenetics’ initial notice or such additional time as is reasonably necessary to obtain any required governmental consents or approval to enter into such agreement, the terms under which Liquidia Neurogenetics will grant such exclusive license to GSK or GSK Bio. If GSK or GSK Bio and Liquidia fail to reach a binding written agreement for the exclusive license by the end of the Negotiation Period, then Liquidia shall be free to negotiate enter into such Business Opportunity with any Third Party for a non-exclusive license within the same applicable field that was the subject of negotiations with GSK or GSK Bio, and to grant such non-exclusive license to any Third Party; provided, that if Liquidia grants such non-exclusive license to a Third Party within nine (9) months after the expiration of Negotiation Period, then the another Person on terms of such Third Party license shall be no less favorable to Liquidia Neurogenetics than the terms those last proposed by GSK or GSK Bio to LiquidiaLilly. Notwithstanding anything in this Agreement to the contrary, the licenses that Liquidia may grant to any Business Opportunity entered into by Neurogenetics with a Third Party in a particular proposed field include Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How, as the case may be, that arises during the Inhaled Collaboration Term or Vaccine Collaboration Term, as the case may be, including after the date of the ROFN Notice, and all such Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How (including any Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How that arises after the expiration of Negotiation Period) shall Person will be thereafter excluded from and not subject to Lilly’s rights under this Section 4.3 as to the particular field proposed to GSK. Further, each time Liquidia desires to grant a non-exclusive license to the Joint Inhaled Collaboration Know-How or Joint Vaccines Collaboration Know-How in a different field than previously proposed to GSK in the right of first negotiation described in this Section 4.3, either to the same Third Party or a different Third Party, then such additional license in a different field shall first be offered to GSK or GSK Bio on the terms set forth above. Subject to Section 4.4 below, Liquidia shall be free to grant non-exclusive licenses to its interest in the Joint Inhaled Collaboration Know-How or Joint Vaccine Collaboration Know-How outside the field of prescription pharmaceutical drugs, products sold on an over-the-counter basis after switching from a prescription basis, or biological products (including biosimilar products) at any time, and the right of first negotiation described in this Section 4.3 shall only apply in the field of prescription pharmaceutical products, pharmaceutical products sold on an over-the-counter basis after switching from a prescription Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. basis, or vaccine or biological products (including biosimilar products). For purposes of this Section 4.3, “biological products” means any products that cause a biological effect in humansAgreement, including, for examplewithout limitation, vaccines, monoclonal antibodies Lilly’s right to receive the milestone payments and cytokinesroyalty payments.
Appears in 1 contract
Sources: Development and License Agreement (TorreyPines Therapeutics, Inc.)