Document:

Unassociated Document

 

SUPPLY AGREEMENT

This SUPPLY AGREEMENT (this “Agreement”) is dated as of June 30, 2005 and is between JUBILANT ORGANOSYS LTD., a company organized under the laws of the Republic of India (“Jubilant”), and TRIGEN LABORATORIES, INC., a Delaware corporation (“Trigen”). Each of Jubilant and Trigen are sometimes referred to herein as a “party” and, collectively, as the “parties.”

RECITALS

WHEREAS, Trigen is engaged in, among other things, the development and manufacture of generic pharmaceutical products;

WHEREAS, Jubilant is engaged in, among other things, the manufacture of active pharmaceutical ingredients;

WHEREAS, Trinity Laboratories, Inc., a Delaware corporation (“Trinity”), owns all of the issued and outstanding capital stock of Trigen;

WHEREAS, Trinity and an Affiliate of Jubilant are parties to that certain Stock Purchase Agreement (the “Stock Purchase Agreement”) dated of even date herewith; and

WHEREAS, the closing of the transactions contemplated by the Stock Purchase Agreement is conditioned upon the parties entering into this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

ARTICLE 1

DEFINITIONS

“Affiliate” means: (a) with respect to a person, any member of such person’s family; and (b) with respect to a person or entity, any person or entity which directly or indirectly, through one or more intermediaries, Controls, is Controlled by, or is under common Control with such person or entity.

“ANDA” means an Abbreviated New Drug Application filed with the FDA. 

 

“API” means an active pharmaceutical ingredient.

 

“cGMP” means current Good Manufacturing Practices promulgated by the FDA and analogous practices promulgated by the governing health authority of any other country in which the Jubilant Products are manufactured.

  

 

  

“Confidential Information” means, with respect to a party, all information of any kind whatsoever (including, without limitation, data, compilations, formulae, models, patent disclosures, procedures, processes, projections, protocols, results of experimentation and testing, specifications, strategies and techniques), and all tangible and intangible embodiments thereof of any kind whatsoever (including, without limitation, apparatus, compositions, documents, drawings, machinery, patent applications, records and reports), which is disclosed by such party or its agents or Affiliates to the other party and is marked or identified as confidential at the time of disclosure to the other party or is of a nature that would reasonably be understood as confidential. Notwithstanding the foregoing, Confidential Information of a party does not include information which the other party can establish by written documentation (a) to have been publicly known prior to disclosure of such information by the disclosing party to the other party, (b) to have become publicly known, without fault on the part of the other party, subsequent to disclosure of such information by the disclosing party to the other party, (c) to have been received by the other party at any time from a source, other than the disclosing party, rightfully having possession of and the right to disclose such information, (d) to have been otherwise known by the other party prior to disclosure of such information by the disclosing party to the other party, or (e) to have been independently developed by employees or agents of the other party without use of such information disclosed by the disclosing party to the other party.

“Control” means possession, directly or indirectly, of power to direct or cause the direction of management or policies (whether through ownership of voting securities, by agreement or otherwise).

“FDA” means the United States Food and Drug Administration and any successor agency thereto.

“FD&C Act” means the Federal Food, Drug and Cosmetic Act and the rules and regulations of the FDA promulgated thereunder.

“Jubilant Product” means an API manufactured by Jubilant or any of its Affiliates and listed on Schedule A attached hereto, as the same may be amended from time to time by written agreement of the parties, provided however, that the specifications of a Jubilant Product shall be as Trigen and Jubilant mutually agree in writing.

“Minority Stockholder Board Designees” is defined in that certain Stockholders Agreement, dated of even date herewith, among Trinity, Jubilant Pharma PTE. Ltd., a company organized under the laws of Singapore, and the other parties signatory thereto.

“Term” is defined in Section 10.1.

“Territory” means the United States of America.

ARTICLE 2

MANUFACTURE, SUPPLY AND PURCHASE

Section 2.1        Supply and Purchase Obligations of Jubilant Products. During the Term, and subject to and upon the terms and conditions of this Agreement, Jubilant shall supply to Trigen, and Trigen shall purchase exclusively from Jubilant, all of Trigen’s requirements for Jubilant Products for use in the Territory. Trigen hereby acknowledges that nothing contained herein precludes Jubilant, whether inside the Territory or outside of the Territory, from manufacturing or supplying Jubilant Products or any APIs to any party other than Trigen.

 

  

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Section 2.2        Manufacturing Practices.

(a)           cGMP; Jubilant Product Specifications. Jubilant shall manufacture the Jubilant Products in accordance with cGMP, the Jubilant Product specifications and applicable laws and regulations.

(b)           Certificates of Analysis. Jubilant shall provide Trigen with a certificate of analysis for each shipment of Jubilant Products manufactured and supplied hereunder, based upon a reference standard established by Jubilant and reasonably acceptable to Trigen, certifying that the Jubilant Products conform to cGMP and Jubilant Product specifications.

Section 2.3        Forecasts and Orders.

(a)           Within ninety (90) days of the date of this Agreement, Jubilant shall provide Trinity with a written list of all APIs manufactured by Jubilant and its Affiliates and that are available for supply by Jubilant to Trigen as Jubilant Products pursuant to this Agreement. Within one hundred twenty (120) days after the date of this Agreement, (i) Jubilant and Trigen shall agree upon the initial Jubilant Products to be supplied by Jubilant to Trigen pursuant to this Agreement, which Jubilant Products shall be set forth on Schedule A attached hereto and signed by each of the parties, and (ii) Trigen shall place a binding purchase order for such Jubilant Products for the third calendar quarter of 2005.

(b)           Thereafter, not later than thirty (30) business days prior to the start of each calendar quarter during the Term, Trigen shall provide to Jubilant a rolling forecast that estimates the quantity of each Jubilant Product to be purchased by Trigen during the upcoming four calendar quarters. The first calendar quarter of each such forecast will constitute a purchase order from Trigen binding on both parties hereto for the amounts forecasted for each Jubilant Product for such calendar quarter. Except for the first calendar quarter of each such rolling forecast, which constitutes a binding purchase order, such forecast will constitute an estimate of Trigen’s requirements for each Jubilant Product, which is supplied for the convenience of Jubilant, is non-binding on Trigen, and will not be constitute an order of Jubilant Product.

(c)           Trigen shall place orders for the Jubilant Products on Trigen’s standard form purchase order on a calendar quarter basis. Each such purchase order must specify each Jubilant Product ordered, the quantity of each Jubilant Product ordered, the place of delivery and the delivery date(s) and the date of shipment which must not be less than thirty (30) days after the date of such purchase order. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, the terms and conditions of this Agreement will prevail.

Section 2.4        Facility and Records Maintenance. Jubilant shall maintain and operate the manufacturing facility(ies) at which the Jubilant Products are manufactured (collectively, the “Facility”) and implement and maintain such quality control procedures, so as to be able to perform its obligations hereunder in compliance with all applicable laws, including without limitation cGMP, and the Jubilant Product specifications. Each party shall promptly notify the other party upon receipt by it of any adverse notice from any governmental agency relating to the Jubilant Products, employees, environmental conditions or the operation of the Facility. Jubilant shall maintain true and complete books and records of all data relating to the manufacture, supply and sale of the Jubilant Products.

 

  

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Section 2.5         Contract Manufacturing. Trigen and Jubilant hereby agree that Jubilant will have the right in connection with Jubilant’s supply obligations hereunder to contract with one or more Affiliates and/or third parties for the manufacture and supply of the Jubilant Products to Trigen; provided, however, that Jubilant shall cause each such Affiliate and third party to comply fully with the terms and conditions set forth in this Agreement with respect to the manufacture and supply of Jubilant Products to Trigen.

ARTICLE 3

PACKAGING, DELIVERY AND ACCEPTANCE

Section 3.1        Delivery of Jubilant Products. Trigen shall provide Jubilant with appropriate instructions for each shipment of Jubilant Products, designating the carrier, destination, method of transport and insurance requirements. All Jubilant Products supplied under this Agreement shall be shipped F.O.B. ex the Facility. Trigen shall pay all freight, insurance charges, taxes, import and export duties, inspection fees and other charges applicable to the sale and transport of the Jubilant Products purchased by Trigen hereunder. Title and risk of loss to the Jubilant Products purchased by Trigen hereunder will pass through to Trigen F.O.B. ex the Facility. All of the Jubilant Product shall be packaged, labeled and marked in accordance with the Jubilant Product specifications. An itemized packing list shall accompany each shipment. Trigen assumes no liability for any Jubilant Products produced, processed or shipped in excess of the amount specified in any purchase order.

Section 3.2        Acceptance and Rejection.

(a)           If a shipment of Jubilant Products or any portion thereof fails to conform to the Jubilant Product specifications, then Trigen may reject such nonconforming shipment or the non­conforming portion thereof, as the case may be. Trigen shall give written notice to Jubilant of its rejection hereunder within fourteen (14) days from date of receipt of Jubilant Product by Trigen, specifying in detail the grounds for such rejection. The non-conforming shipment of Jubilant Products, or the non-conforming portion thereof, shall be held for Jubilant’s disposition, or shall be returned to Jubilant, in each case at Jubilant’s expense, as directed by Jubilant. Jubilant shall use commercially reasonable efforts to replace the non-conforming shipment of Jubilant Products, or the non-conforming portion thereof, with conforming Jubilant Products as soon as reasonably practicable after receipt of notice of rejection thereof, and in any event will ship conforming Jubilant Products within thirty (30) days after receipt of notice of rejection thereof at no cost to Trigen. Jubilant shall make arrangements with Trigen for the return or destruction, at Jubilant’s option and cost, of any rejected Jubilant Products. All such return shipping charges or costs of destruction shall be paid by Jubilant.

(b)           In the event that Trigen has paid for rejected Jubilant Products, and such Jubilant Products have not been satisfactorily replaced, Jubilant shall promptly refund or, at Trigen’s option, extend a credit to Trigen for the full amount paid by Trigen for such Jubilant Products or dispute such claim and, if necessary, initiate dispute resolution in accordance with Section 3.2(c).

 

  

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(c)            In the event of a conflict regarding any nonconforming Jubilant Products which Jubilant and Trigen are unable to resolve, a sample of such Jubilant Products, together with mutually agreed upon questions, shall be submitted by Trigen to an independent laboratory reasonably acceptable to both parties for testing against the Jubilant Product specifications. The test results obtained by such laboratory will be final and binding upon the parties. The fees and expenses of such laboratory testing, and all additional shipping and transportation costs incurred as a result of the dispute, shall be borne entirely by the party against whom such laboratory’s findings are made. In the event the test results obtained by such laboratory indicate that the Jubilant Products in question do not conform to the Jubilant Product specifications, Jubilant shall replace such Jubilant Products with conforming Jubilant Products in accordance with this Section 3.2.

ARTICLE 4

PRICE AND PAYMENT TERMS

Section 4.1        Purchase of Jubilant Products. Subject to Section 2.1, Trigen shall purchase from Jubilant each shipment of Jubilant Products accepted pursuant to Section 3.2. The price for each Jubilant Product will be the lowest price at which Jubilant is then selling such Jubilant Product to any non-Affiliate customer in the Territory. If a Jubilant Product is not being sold to a non-Affiliate customer in the Territory, then the price for such Jubilant Product shall be as mutually agreed in writing by the parties.

Section 4.2        Invoicing. Upon shipment of Jubilant Products to Trigen, Jubilant shall submit invoices therefor to Trigen. Trigen shall pay each invoice in full within sixty (60) days from the date of shipment by Jubilant. In the event any invoice is disputed by Trigen in good faith, Trigen shall remit payment for the undisputed portion of such invoice and the parties shall cooperate in good faith to resolve any such dispute. Trigen shall make all payments due hereunder in U.S. Dollars.

Section 4.3        Sales and Use Taxes. Trigen shall be solely responsible for the payment of all federal, state or local taxes, use or value added taxes, excise or similar charges, or other tax assessments (including that assessed against income), assessed or charged on the sale of the Jubilant Products to Trigen pursuant to this Agreement.

ARTICLE 5

FURTHER OBLIGATIONS OF THE PARTIES

Section 5.1        Facility Qualification. Jubilant shall, at no cost to Trigen, take all such actions to promptly qualify with the FDA (and thereafter to maintain qualification of) the Facility, as required under applicable law in the United States, including, without limitation, cGMP.

Section 5.2        Exclusive Marketing, Until the earlier of (i) the date on which Trinity becomes a reporting company under the Securities Exchange Act of 1934, as amended from time to time, and (ii) December 31, 2008, Jubilant shall, within the Territory, market each of its finished dosage form generic pharmaceutical products exclusively through Trigen; provided, however, that in the event Jubilant elects to market any generic finished dosage form pharmaceutical product that may result from the pre-ANDA products provided by Jubilant to Trigen pursuant to Section 5.3, Jubilant shall market such generic finished dosage form pharmaceutical products in the Territory exclusively through Trigen during the term of this Agreement.

 

  

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Section 5.3        Jubilant ANDAs. Jubilant shall provide to Trigen an aggregate of ten (10) pre-ANDA products (inclusive of pilot bio-studies), of which five (5) shall be provided without cost, and five (5) shall be provided at a cost of two hundred fifty thousand dollars (US $250,000) dollars each. Jubilant shall exercise commercially reasonable efforts to provide such pre-ANDA products to Trigen as soon as commercially practicable; provided, however, that Jubilant shall in any event provide such pre-ANDA products to Trinity within a period of three (3) years from the date of this Agreement; provided, however, that such three (3) year period may be extended by Jubilant for up to six (6) months. Trigen shall be entitled to choose the pre-ANDA products based on APIs developed or under development by Jubilant; provided, however, that the cost of APIs of the referenced products shall be borne entirely by Trigen. Trigen and Jubilant shall mutually agree upon the pre-ANDA products to be selected, the dates on which such pre-ANDA products will be transferred to Trigen, and the payment dates for the same.

Section 5.4        Further Obligations of Jubilant. During the Term, Jubilant shall:

(a)           Promptly respond to all reasonable inquiries from Trigen pertaining to the supply of the Jubilant Products.

(b)           Conduct stability testing in accordance with cGMP requirements and the Jubilant Product specifications.

Section 5.5        Further Obligations of Trigen. During the Term, Trigen shall:

(a)           Promptly respond to all reasonable inquiries from Jubilant pertaining to the supply of the Jubilant Products.

(b)           Promptly notify Jubilant of any comments, responses or notices received from the FDA, or other applicable regulatory authorities, which relate to or may impact any Jubilant Product or any product in which a Jubilant Product is incorporated.

ARTICLE 6

REPRESENTATIONS, WARRANTIES AND COVENANTS

Section 6.1        Jubilant’s Representations, Warranties and Covenants. Jubilant hereby represents and warrants to Trigen and covenants as follows:

(a)           Jubilant is a corporation duly organized and validly existing under the laws of the Republic of India.

(b)           Jubilant has the requisite power and authority to execute and deliver this Agreement and to perform fully its obligations hereunder, including, without limitation, supplying the Jubilant Products to Trigen in accordance with the terms of this Agreement.

  

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(c)           All Jubilant Products delivered by Jubilant to Trigen shall, at the time of shipment, have been formulated, manufactured, packaged and stored by Jubilant in conformity with cGMP and the Jubilant Product specifications and shall not be adulterated or otherwise violative of the FD&C Act or other applicable law.

(d)           The execution of this Agreement by Jubilant and the full performance of Jubilant’s obligations hereunder are not and will not be in violation of or in conflict with any material obligation Jubilant has to any third party.

(e)           Jubilant is not debarred and Jubilant has not and will not use in any capacity the services of any person debarred under subsection 306(a) or (b) of the Generic Drug Enforcement Act of 1992.

(f)           There are no pending investigations, adverse third party allegations or actions, or claims against Jubilant, or to Jubilant’s knowledge, threatened action against Jubilant in any court or by or before any governmental body or agency, with respect to any Jubilant Product, the Facility or Jubilant’s obligations set forth herein which may adversely affect Jubilant’s ability to perform fully its obligations under this Agreement.

(g)           Jubilant shall obtain and maintain throughout the Term all necessary and material licenses, permits or approvals required by the FDA or other relevant governmental agency in connection with the manufacturing, packaging, storage and shipment of the Jubilant Products, and the performance of its other obligations hereunder, including, without limitation, permits relating to the Facility.

(h)           The Jubilant Products delivered to Trigen pursuant to this Agreement, at the time of delivery, shall be free and clear of all liens, security interests or other encumbrances.

(i)           The Jubilant Products delivered to Trigen pursuant to this Agreement do not and shall not infringe or misappropriate any patent, trade secret, or other intellectual property right of any third party.

(j)           EXCEPT FOR THE REPRESENTATIONS, WARRANTIES AND COVENANTS EXPRESSLY MADE IN THIS AGREEMENT, JUBILANT MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE JUBILANT PRODUCTS, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

Section 6.2        Trigen’s Representations, Warranties and Covenants. Trigen hereby represents and warrants to Jubilant and covenants as follows:

(a)           Trigen is a corporation duly organized and validly existing under the laws of the State of Delaware.

(b)           Trigen has the requisite corporate power and authority to execute and deliver this Agreement and to perform fully its obligations hereunder.

(c)           The execution of this Agreement by Trigen and the full performance of Trigen’s obligations hereunder are not and will not be in violation of or in conflict with any material obligations Trigen has to any third party.

 

  

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(d)           Trigen is not debarred and Trigen has not and will not use in any capacity the services of any person debarred under subsections 306(a) or (b) of the Generic Drug Enforcement Act of 1992.

(e)           Trigen has and will maintain throughout the term of this Agreement all material permits necessary for Trigen to perform fully its obligations hereunder in accordance with applicable law.

(f)           There are no pending investigations, adverse third party allegations or actions, or claims against Trigen, or to Trigen’s knowledge, threatened action against Trigen in any court or by or before any governmental body or agency, with respect to any Jubilant Product or Trigen’s obligations set forth herein which may adversely affect Trigen’s ability to perforin fully its obligations under this Agreement.

ARTICLE 7

INDEMNIFICATION

Section 7.1        Jubilant’s Indemnity Obligations. Jubilant shall defend, indemnify and hold harmless Trigen, its Affiliates and their respective successors and permitted assigns (and the respective officers, directors, stockholders, partners and employees of each) from and against any and all losses, liabilities, claims, actions, proceedings, damages and expenses (including, without limitation, reasonable attorneys fees and expenses) (collectively, “Damages”) to the extent arising out of any breach of this Agreement by Jubilant or its Affiliates (exclusive of Trigen and Trinity Laboratories, Inc.), except to the extent such Damages give rise to an indemnification claim against Trigen under Section 7.2.

Section 7.2        Trigen’s Indemnity Obligations. Trigen shall defend, indemnify and hold harmless Jubilant and its Affiliates, and their respective successors and permitted assigns (and the respective officers, directors, stockholders, partners and employees of each) from and against any and all Damages to the extent arising: (a) out of the handling, possession, use, marketing, distribution or sale by Trigen or its Affiliates (exclusive of Jubilant and is Affiliates other than Trigen and Trinity Laboratories, Inc.) or any of their distributors or agents of any products containing any Jubilant Product supplied under this Agreement; or (b) out of any breach by Trigen or its Affiliates (exclusive of Jubilant and its Affiliates other than Trigen and Trinity Laboratories, Inc.) of this Agreement, except to the extent such Damages give rise to an indemnification claim against Jubilant under Section 7.1.

  

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Section 7.3        Indemnification. A party that intends to make a claim indemnification under this ARTICLE 7 (the “Indemnitee”) shall notify the other party (the “Indemnitor”) promptly in writing of any action, claim or liability in respect of which the Indemnitee believes it is entitled to claim indemnification, provided that the failure to give timely notice to the Indemnitor shall not release the Indemnitor from any liability to the Indemnitee except to the extent the Indemnitor is prejudiced thereby. The Indemnitor shall have the right, by notice to the Indemnitee, to assume the defense of any such action or claim within fifteen (15) days after the Indemnitor’s receipt of notice of any action or claim with counsel of the Indemnitor’s choice and at the sole cost of the Indemnitor. If the Indemnitor so assumes such defense, the Indemnitee may participate therein through counsel of its choice, but at the sole cost of the Indemnitee. The party not assuming the defense of any such claim shall render all reasonable assistance to the party assuming such defense, and all reasonable out of pocket costs of such assistance shall be for the account of the Indemnitor. No such claim shall be settled other than by the party defending the same, and then only with the consent of the other party which shall not be unreasonably withheld or delayed; provided that the Indemnitee shall have no obligation to consent to any settlement of any such action or claim which imposes on the Indemnitee any liability or obligation which cannot be assumed and performed in full by the Indemnitor, and the Indemnitee shall have no right to withhold its consent to any settlement of any such action or claim if the settlement involves only the payment of money by the Indemnitor or its insurer.

 

Section 7.4        Limitations on Indemnification. Notwithstanding any contrary provision herein no party will be entitled to indemnification with respect to any claim or suit to the extent such claim or suit results from its own gross negligence or willful misconduct.

 

ARTICLE 8

RELATIONSHIP BETWEEN THE PARTIES

Nothing contained in this Agreement will be deemed to constitute a partnership or joint venture between Jubilant and Trigen or to constitute one as the agent of the other. Jubilant and Trigen shall act solely as independent contractors, and nothing in this Agreement will be construed to give either party the power or authority, express or implied, to act for, bind, or commit the other party.

ARTICLE 9

CONFIDENTIALITY AND PUBLIC DISCLOSURE

Each party shall treat as confidential the Confidential Information of the other party, and shall take all necessary precautions to assure the confidentiality of such information. Each party shall to return to the other party upon the expiration or termination of this Agreement all Confidential Information acquired from such other party, except as to such information it may be required to retain under applicable law or regulation, and except for one copy of such information to be retained by such party’s legal counsel. Neither party shall, during the period of this Agreement and for five (5) years thereafter, or for an indefinite period with respect to any Confidential Information that is a trade secret, without the other party’s express prior written consent, use or disclose any such Confidential Information for any purpose other than to carry out its obligations hereunder. Each party, prior to disclosure of such Confidential Information to any employee, consultant or advisor shall ensure that such person is bound in writing to observe the confidentiality provisions of this Agreement. The obligations of confidentiality will not apply to information that the receiving party is required by law or regulation to disclose; provided, however, that the receiving party shall so notify the disclosing party of its intent and cooperate with the disclosing party on reasonable measures to protect the confidentiality of such Confidential Information.

  

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ARTICLE 10

TERM AND TERMINATION

Section 10.1      Term. The term (the “Term”) of this Agreement shall commence on the date hereof and be determined separately for each Jubilant Product on a Jubilant Product-by-Jubilant Product basis. The Term for each Jubilant Product shall commence on the date that the FDA approves an ANDA (an “FDA Approval Date”) for a product incorporating such Jubilant Product and shall terminate on the fifth (5th) anniversary of the FDA Approval Date of the product incorporating such Jubilant Product, unless earlier terminated pursuant to Section 10.2; provided, however, that the Term with respect to each Jubilant Product may be extended for one additional five-year period, upon written agreement of the parties.

Section 10.2      Termination. Prior to the expiration of the Term, this Agreement may be terminated:

(a)           upon the mutual written consent of Trigen and Jubilant; provided that such termination is first approved or consented to by the Board of Directors of Trinity, including the Minority Stockholder Board Designees; or

(b)           in the event either party ceases conducting business in a normal course, becomes insolvent, makes a general assignment for the benefit of creditors, suffers or permits the appointment of a receiver for its business or assets, or avails itself of, or becomes subject to, any proceeding under the Federal Bankruptcy Act or any other statute of any state or country relating to insolvency or the protection of creditor rights, the other party shall have a right to terminate this Agreement, provided that in the case of an involuntary bankruptcy proceeding such right to terminate shall only become effective if the other party consents thereto or such proceeding is not dismissed within ninety (90) days after the filing thereof.

Section 10.3      Effect of Expiration and Termination. Expiration or termination of this Agreement shall not relieve the parties of any obligation accruing prior to such expiration or termination, including, without limitation, any liability or loss arising from a breach of this Agreement. The provisions of ARTICLE 6, ARTICLE 7 and ARTICLE 9 shall survive any expiration or termination of this Agreement.

ARTICLE 11

MISCELLANEOUS

Section 11.1      Notices. All notices or other communications given pursuant hereto by one party to the other party shall be in writing and deemed given (a) when delivered by messenger, (b) when sent by telecopier (with receipt confirmed), (c) when received by the addressee, if sent by Express Mail, FedEx or other express delivery service (receipt requested), or (d) five days after being mailed via U.S. first-class postage prepaid, registered or certified, in each case to the appropriate addresses and telecopier numbers set forth below (or to such other addresses and telecopier numbers as a party may designate by notice to the other party):

 

  

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If to Trigen:

Trigen Laboratories, Inc.

207 Kiley Drive

Salisbury, Maryland 21801

Telecopier: (410) 860-8719

Attention: Ram Potti

If to Jubilant:

Jubilant Organosys Ltd.

I-A, Sector 16A

Institutional Area

Noida,U.P. 201301, India

Telecopier: +91 120 2516629

Attention: Shyam S. Bhartia

Section 11.2      Assignment. Neither party may assign or otherwise transfer this Agreement or any right or obligation hereunder (except in connection with the transfer or sale of all or substantially all of its business, or in the event of its merger, consolidation, change in control or similar transaction, or otherwise) without the prior written consent of the other party, which consent shall not be unreasonably withheld or delayed.

Section 11.3      Severability. If any provision of this Agreement is held unenforceable by any court of competent jurisdiction, all other provisions of this Agreement will remain effective. If any provision of this Agreement is held to be unenforceable only in part or degree, it will remain effective to the extent not held unenforceable.

Section 11.4      Entire Agreement. This Agreement constitutes the entire agreement of the parties pertaining to the subject matter of this Agreement. It supersedes all prior agreements of the parties, whether oral or written, pertaining to the subject matter of this Agreement.

Section 11.5      Amendment. Schedule A to this Agreement may be amended to add, remove, or otherwise modify Jubilant Products and the transfer price for the Jubilant Products by written agreement of the parties. All other amendments to this Agreement will require both (1) the written agreement of the parties, and (2) the prior approval or consent of the Board of Directors of Trinity, including the Minority Stockholder Board Designees.

Section 11.6      No Waiver. The failure of either party to require performance by the other party of any of the other party’s obligations hereunder will in no manner affect the right of such party to enforce the same at a later time. No waiver by either party hereto of any condition, or of the breach of any provision, term, representation or warranty contained in this Agreement, whether by conduct or otherwise, in any one or more instances, will be deemed to be or construed as a further or continuing waiver of any such condition or breach, or of any other condition or of the breach of any other provision, term, representation or warranty hereof.

Section 11.7      Governing Law. This Agreement, the rights and obligations of the parties hereto, and any claims or disputes relating thereto, shall be governed by and construed in accordance with the laws of the State of New York (excluding the choice of law rules thereof).

  

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Section 11.8      Arbitration. In the event of a breach of this Agreement by any party, or any dispute hereunder, such dispute shall be settled by a panel of three (3) arbitrators in Newark, New Jersey (one of whom shall be selected by the Jubilant, one of whom shall be selected by Trigen and the third of whom shall be selected by the arbitrators selected by Jubilant and Trigen) who shall hold a hearing and make an award within sixty (60) days of filing. The arbitrators shall be selected and the proceedings and award conducted in accordance with the rules of the American Arbitration Association then pertaining. The arbitrators, in addition to any award that they shall make, shall have the discretion to award the prevailing party the costs of the proceedings together with attorneys’ fees. Any award made hereunder may be docketed in a court of competent jurisdiction. In the event there are any issues which are not arbitrable as a matter of law, as a condition precedent to a court making a determination of any non-arbitrable issues, any issues which may be arbitrated shall first be determined by arbitration pursuant to this section. Nothing in this Section 11.8 shall prohibit any party hereto from seeking injunctive relief from a court of competent jurisdiction in order to preserve or enforce such party’s rights hereunder.

Section 11.9      Headings. The headings contained in this Agreement are for convenience of reference only and shall not constitute a part hereof or define, limit or otherwise affect the meaning of any of the terms or provisions hereof.

Section 11.10    Counterparts. This Agreement may be executed in one or more counterparts, including by facsimile, each of which will be deemed an original, but all of which, when taken together, will constitute one and the same instrument.

Section 11.11    Force Majeure. If either party is prevented from complying, either totally or in part, with any of the terms or provisions set forth herein by reason of force majeure including, by way of example and not of limitation, fire, flood, explosion, storm, strike, lockout or other labor dispute, riot, war, rebellion, accidents, acts of God, acts of governmental agencies or instrumentalities, failure of suppliers or any other cause or externally induced casualty beyond its reasonable control, whether similar to the foregoing contingencies or not, said party shall provide written notice of same to the other party. Said notice shall be provided within five (5) business days of the occurrence of such event and shall identify the requirements of this Agreement or such of its obligations as may be affected, and to the extent so affected, said obligations shall be suspended during the period of such disability. The party prevented from performing hereunder shall use reasonable good faith efforts to remove such disability, and shall continue performance whenever such causes are removed. The party so affected shall give to the other party a good faith estimate of the continuing effect of the force majeure condition and the duration of the affected party’s non-performance. When such circumstances arise, the parties shall discuss what, if any, modification of the terms of this Agreement may be required in order to arrive at an equitable solution.

 

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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their respective duly authorized officers as of the date first above written.

	
JUBILANT ORGANOSYS LTD.

	  	  
	
By:

	/s/ R. Sankaraiah
	  	
Name: R. Sankaraiah

	  	
Title:

	
TRIGEN LABORATORIES, INC.

	  	  
	
By:

	/s/ P. Jagan Reddy
	  	
Name: P. Jagan Reddy

	  	
Title:

 

  

 

  

 

SCHEDULE A

JUBILANT PRODUCTS

Jubilant Product

	
JUBILANT ORGANOSYS LTD.

	  	
TRIGEN LABORATORIES, INC.

	  	  	  
	
By:

	  	  	
By:

	  
	  	
Name:

	  	  	
Name:

	  	
Title:

	  	  	
Title:

	  	
Date:

	
  

	  	
Date:Unassociated Document

Execution Version

 

MASTER SUPPLY AGREEMENT

 

THIS MASTER SUPPLY AGREEMENT (the “Agreement”), dated as of May 27, 2011 (the “Effective Date”) by and between Jubilant Life Sciences Ltd., a company organized under the laws of India (“Jubilant”) and Jubilant Cadista Pharmaceuticals, Inc., a Delaware corporation, (“Cadista”). (Cadista and Jubilant are sometimes referred to herein individually as a “Party” and collectively as the “Parties”).

Cadista is interested in buying and selling in the Territory certain of Jubilant’s products manufactured by Jubilant.

Accordingly, in consideration of the mutual promises, covenants and agreements hereinafter set forth, the Parties agree to the following terms and conditions:

ARTICLE I - DEFINITIONS

“AB Rated Equivalent” means a product which has been approved by the FDA which meets the necessary bioequivalence requirements through in vivo and/or in vitro testing compared to a reference standard that is currently approved.

“Accepted Product” has the meaning set forth in Section 6.4(a).

           “Affiliate” means any entity that directly or indirectly Owns, is Owned by, or is under common Ownership with a Party to this Agreement. “Owns” or “Ownership” means direct or indirect possession of more than fifty percent (50%) of the votes of holders of a corporation’s voting securities or a comparable equity interest in any other type of entity. For purposes of this Agreement Cadista and Jubilant shall be deemed not to be Affiliates of each other.

“Agency” means any governmental regulatory authority responsible for granting approvals for the sale of a Product.

            “Agreement” means the present agreement together with all attachments.

“ANDA” means an “abbreviated new drug application,” as defined in the FD&C Act and applicable FDA rules and regulations.

“API” means the active pharmaceutical ingredient of a particular Product.

“Applicable Law” means, with respect to any Person, any domestic or foreign, federal, state or local statute, treaty, law, ordinance, rule, regulation, administrative interpretation, order, writ, injunction, judicial decision, decree or other requirement of any Governmental Authority applicable to such Person or any of such Person’s respective properties, assets, officers, directors, employees, consultants or agents.

[***Confidential treatment requested pursuant to a request for confidential treatment filed with the 

Securities and Exchange Commission. Omitted portions have been separately filed with the Commission.]

 

  

  

  

 

“Average Selling Price” means with respect to a Product for any period, (A) the gross sales (number of units shipped times the invoiced price per unit) by Cadista, its distributors or sublicensees, for such period less accruals for expected rebates and retroactive price reductions for Product shipped during such period and any applicable prior periods, divided by (B) the number of units of Product shipped by Cadista for such period.

 

“Alternate Supplier” has the meaning set forth in Section 6.2.

 

“Approved Manufacturer” has the meaning set forth in Section 6.6.

“Article” means any article of this Agreement.

“Bankruptcy Code” means 11 USC §§ 101, et seq.

“Business Day” means a day other than a Saturday, Sunday or other day on which commercial banks in New York, New York, USA are authorized or required by law to close.

 

“Cadista” has the meaning set forth in the preamble.

 “cGMP” means the FDA’s then-current Good Manufacturing Practices applicable to the manufacture of pharmaceutical products for human use in the United States, the FDA’s guidance documents, and all successor regulations.

 

“Commercially Reasonable Efforts” means exercising such reasonable efforts and diligence in accordance with a Party’s reasonable business, legal, medical and scientific judgment and in a manner consistent with and in accordance with the efforts and resources of similar parties in the industry for a pharmaceutical product owned or controlled by such Party which is of similar market potential at a similar stage of its product life, taking into account the competitiveness of the marketplace, the proprietary position of the product and the profitability of the product.

 

“Components” means, collectively, all packaging components, raw materials and ingredients (including labels, product inserts and other labeling for the Product), required to be used in order to produce a Product in accordance with the Product Specifications, other than the API.

“Competing Product with respect to a Product shall mean any pharmaceutical product which has the same active ingredients in the same dosage form, as such Product and is a Generic Equivalent.

“Confidential Information” has the meaning set forth in Article X.

“Destination Charges” means all amounts paid or incurred by Cadista for Product to reach Cadista’s warehouse (including without limitation, taxes, customs, insurance and shipping).

 

  

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“Effective Date” has the meaning set forth in the preamble.

“FD&C Act” means the Federal Food, Drug and Cosmetic Act, as amended, and the rules and regulations of the FDA promulgated thereunder.

“FDA” means the United States Food and Drug Administration, or any successor thereto.

“GAAP” means generally accepted accounting principles in effect in the United States from time to time applied on a consistent basis.

 

“Generic Equivalent” means an AB Rated Equivalent of the innovator product described in Schedule 1.

 

“Governmental Authority” means any foreign, domestic, federal, territorial, state or local governmental authority, quasi-governmental authority, instrumentality, court, government or self-regulatory organization (including any securities exchange), commission, tribunal or organization or any regulatory, administrative or other agency, or any political or other subdivision, department or branch of any of the foregoing.

 

“Intellectual Property Rights” means any and all existing and future proprietary rights, including but not limited to property rights, know-how rights, trade secret rights, copyrights, design rights, any existing or future patents and patent applications in the Territory and all continuations, continuations-in-part, divisions, reissues, reexaminations, extensions or other government actions which extend the subject matter of the foregoing, and any corresponding patents, patents of addition, granted or registered and all other intellectual property rights (including without limitation the right, if any, to sue or bring other actions for past, present and future infringement of such Intellectual Property Rights).

 

“Jubilant” has the meaning set forth in the preamble.

“Label”, “Labeled” or “Labeling” means, when used as a noun, all labels and other written, printed or graphic matter upon (i) a Product or any container or wrapper utilized with such Product, or (ii) any written material accompanying such Product, including, without limitation, package inserts, in each case that is subject to FDA review.  When used as verb, Label means to affix or insert a Label.

“Latent Defect” has the meaning set forth in Section 6.4(a).

“Loss” or “Losses” has the meaning set forth in Section 12.1.

“Marketing Plan” has the meaning set forth in Section 5.2.

“NDA” means a New Drug Application filed with the FDA pursuant to and under 21 U.S.C. Section 355(b) of the FD&C Act.

 

  

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“Net Sales” means with respect to a Product for any period, the Average Selling Price for such period multiplied by the number of units shipped for such period  less the following, to the extent not included in the Average Selling Price and without duplication: (a) rebates, quantity and cash discounts, promotional allowances, and other usual and customary discounts and wholesaler or other fees to customers, (b) taxes and duties paid, absorbed, or allowed which are directly related to the sale, (c) the amount of chargebacks and amounts repaid or credited by reason of rejections, damages or return of goods (including, without limitation, for customer returns of Product for any reason, including remaining shelf life), or because of retroactive price adjustments justified by trade practices, and (d) discounts, rebates or other payments required by law to be made under Medicaid, Medicare, or other governmental special medical assistance programs.  To the extent returns are refunded under Section 7.8, they shall not be deducted from Net Sales.

“out-of-product costs” means costs and expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with GAAP) other than Affiliates and employees, by either Party.

“Package” or “Packaging” means, when used as a noun, all primary and secondary containers, including cartons, shipping cases and other like matter used in packaging or accompanying a Product.  When used as a verb, “Package” means to insert into a Package.

“Party” has the meaning set forth in the preamble.

 

“Person” means an individual, a corporation, a general partnership, a limited partnership, a limited liability company, a limited liability partnership, an association, a trust or any other entity or organization, including a Governmental Authority.

 

“Product Claim” has the meaning set forth in Section 12.3.

“Product Purchase Price” shall be determined on a Product-by-Product basis for a Product and is defined in Section 7.1.

Product Specifications” means the specifications for each of the Products that has received FDA approval set forth on Exhibit A and the specifications to be set forth on Exhibit A following receipt of FDA approval for other Products, as the same may be amended by the Parties from time to time including and in connection with the addition or deletion of Products from Schedule 1.

 

“Products” means each of the finished dosage pharmaceutical products listed and described on Schedule 1 attached hereto in the dosage form set forth therein, as Schedule 1 may be amended by mutual agreement of the Parties.

“Recall” has the meaning set forth in Section 6.5.

“Regulatory Approval” means the license or marketing approval necessary as a prerequisite for marketing a Product in the Territory.

 

  

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“Rejection Notice” has the meaning set forth in Section 6.4(a).

“Renewal Period” has the meaning set forth in Section 9.1.

“Section” means any section of this Agreement.

“Service Level Charges” is defined in Section 6.2.

“Technical Information” means all techniques and data and other know-how and technical information including inventions (including patentable inventions), practices, methods, concepts, know-how, trade secrets, documents, computer data, source code, apparatus, clinical and regulatory strategies, test data, analytical and quality control data, manufacturing, patent data or descriptions, development information, drawings, specifications, designs, plans, proposals and technical data and manuals and all other proprietary information concerning the development, manufacture, production, quality control, storage, distribution and sale of a Product.

“Term” means the period of time specified in Section 9.1.

“Territory” means the United States (including all of its states, territories and possessions).

“Third Party” means any entity other than Jubilant or Cadista, and their respective Affiliates.

 

ARTICLE II - OVERVIEW OF AGREEMENT

2.1           Overview.  Jubilant will manufacture, Label and Package, or have its designee manufacture, Label and Package, the Products and supply the Products to Cadista, and Cadista will market, sell and distribute the Products in the Territory.  The Parties acknowledge and agree that additional Products may be added to this Agreement, from time to time, upon the mutual agreement of the Parties and the execution of a revised Schedule 1 to add such additional Products.

ARTICLE III – TECHNICAL INFORMATION/COMPETING PRODUCTS

3.1           Ownership of Technical Information.  Ownership of inventions, whether patentable or not patentable, and Technical Information developed pursuant to this Agreement shall be owned by the developing Party.

3.2           Covenant Not to Market Competing Products. From and after the Effective Date until the termination of this Agreement, Cadista shall not directly or indirectly manufacture for sale, market or sell a Competing Product to a Product in the Territory.  This restriction shall not apply with respect to a particular Product once the Term has ended with respect to such Product.   Notwithstanding the foregoing, the Parties recognize and agree that Persons to whom Cadista sells Products for further distribution may also without the assistance of Cadista sell Competing Products.

 

  

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ARTICLE IV

GENERAL COMMERCIAL OBLIGATIONS

 

4.1           Appointment.  Jubilant hereby appoints Cadista as exclusive distributor of the Products in the Territory.  During the Term of this Agreement for a Product, Jubilant hereby grants Cadista the exclusive rights to market, advertise, promote, distribute, sell and offer to sell the Products in the Territory.

 

4.2           Supply.  Subject to the terms and conditions of this Agreement, from and after the Effective Date and during the Term: (a) Jubilant shall use Commercially Reasonable Efforts to timely manufacture, Label, Package and supply to Cadista all of Cadista’s requirements of each of the Products for use or sale in the Territory in accordance with Cadista’s purchase orders, the Product Specifications for each Product, cGMP requirements, Applicable Law and the terms hereof; (b) Jubilant shall not manufacture the Products for, or supply the Products to, its Affiliates (other than Cadista) or any Third Party for use or sale within the Territory without the prior written consent of Cadista; and (c) except as provided in Sections 6.2 and 6.6, Cadista shall purchase all of its requirements of the Products for use or sale in the Territory exclusively from Jubilant.

 

4.3           Packaging and Labeling.  Cadista shall supply to Jubilant, in a timely fashion, all information necessary to create artwork required to Label the Products (including private-label Product, where applicable) with such trademarks, logos or designs as Cadista shall select and in accordance with Applicable Laws.  Jubilant shall be responsible for securing any approvals required by Agencies in the Territory or other applicable Regulatory Approvals for the initial Label for the Products and for any changes or supplements to the Labeling for any Product requested by Cadista.  In the event that Cadista wishes to modify or change the Label for a Product, when and where reasonably practicable, Cadista shall provide at least sixty (60) days’ advance notice of such desired change to Jubilant as reasonably possible and forward such modifications or changes to Jubilant for incorporation into the Packaging and Labeling of such Products.

 

4.4           Regulatory Approval. (a) Jubilant, at its cost, shall use Commercially Reasonable Efforts to expeditiously obtain FDA approval of the ANDAs, for each Product, and shall own all Regulatory Approvals for each Product, including without limitation, all ANDAs for each Product.  Jubilant shall (i) conduct all correspondence with the FDA and otherwise manage the Product Regulatory Approval process; (ii) use Commercially Reasonable Efforts to satisfy any deficiencies identified by the FDA; and (iii) use Commercially Reasonable Efforts to maintain the Regulatory Approvals of such Product.

 

(b)           Jubilant shall maintain the Regulatory Approvals for the Products with the FDA including, the filing of annual reports with the FDA, the performance and submission of stability studies on batches of such Product as may be required under FDA regulations and the preparation and filing of any notices, amendments or supplements as may be required to change or add another source of supply of the APIs for such Product.

 

  

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ARTICLE V

COMMERCIALIZATION

 

5.1           General Diligence Obligation.  Subject to the terms and conditions of this Agreement, Cadista will exercise Commercially Reasonable Efforts to market and promote the Products to customers in the Territory during the Term in accordance with the terms of this Agreement, and with Applicable Law.

5.2           Marketing Plan.  Cadista will be responsible for assessing the market opportunities for each Product in the Territory and preparing and providing to Jubilant, a marketing plan for such Product (each a “Marketing Plan”) for the current calendar year within 60 days after the Effective Date of this Agreement.  Each Marketing Plan shall set forth, among other things, Cadista’s Expected Market Price (as defined in Section 5.3 below) for a Product, the estimated Net Sales of such Product for such calendar year and Cadista’s proposed marketing activities, which must be consistent with efforts appropriate for pharmaceuticals products of similar market potential to market such Product in the Territory.

 

Thereafter, Cadista shall, ninety days prior to the end of each calendar year during the Term, provide Jubilant with a copy of Cadista’s Marketing Plan for each Product for the next calendar year.  Jubilant may communicate comments to Cadista in respect of such Marketing Plans.  Cadista agrees to consider such comments in good faith and shall provide a response to Jubilant in respect of such comments, which response may include revisions to the Marketing Plan.  Cadista shall adopt Jubilant’s comments unless commercially unreasonable.

5.3           Product Sale Pricing.  The net selling prices at which Cadista will market and sell each Product shall be mutually determined by the Parties promptly following Jubilant’s receipt of Cadista’s Marketing Plan for such Product (the “Expected Market Price”).  In the event Product is to be sold below the Expected Market Price, whether in general or as to a specific customer, Cadista shall obtain the approval of Jubilant, and the Product Purchase Price for such Product payable by Cadista to Jubilant pursuant to Section 7.1 shall be adjusted accordingly.  Cadista may request adjustments to the Expected Market Price for a Product as and when market conditions for such Product in the Territory require changes to the Expected Market Price of such Product.

 

ARTICLE VI

DELIVERY AND ACCEPTANCE

 

6.1           Forecasts.  Within 60 days after the execution of this Agreement and, not later than 90 days prior to the end of each calendar year during the Term, Cadista will provide Jubilant with a forecast of its requirements of each Product for such calendar year.  All forecasted requirements of each Product provided by Cadista to Jubilant pursuant to this Agreement constitute an estimate of Cadista’s requirements for such Product that is supplied for the convenience of Jubilant only, is non-binding on Cadista, and will not itself be deemed an order of such Product.

 

  

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6.2           Orders.  On a quarterly basis during the Term of this Agreement, Cadista shall submit to Jubilant purchase orders as needed for each Product to be delivered no sooner than ninety (90) calendar days after the date of the purchase order, consistent with its forecast and as required by Cadista.  Jubilant shall use Commercially Reasonable Efforts to supply a quantity of each Product of up to one-hundred twenty-five percent (125%) of the amount previously forecasted for such Product by Cadista for any such quarter.

 

If Jubilant cannot confirm that it will be able to supply at least ninety percent (90%) of the quantities of any Product estimated by Cadista for the current 3-month portion of the forecast, as Cadista’s sole remedy, Cadista will advise Jubilant of any service level charges or penalties that may accrue (i.e. payments by Cadista to customer for failure to timely supply) on account of the delay or non-supply and Jubilant shall bear those charges and penalties (“Service Level Charges”).  In the event that the terms and conditions of any purchase order are inconsistent with or conflict with the terms and conditions of this Agreement, the terms and conditions of this Agreement shall govern.  Jubilant shall, within five (5) Business Days of receiving each purchase order, acknowledge and confirm the delivery date of such Product described on such purchase order.

 

6.3           Delivery of Products.  Delivery of Products shall be FOB place of manufacture, freight prepaid with full insurance, no later than the delivery date specified by Cadista and no later than 60 days from the date of manufacture.  A Certificate of Analysis, signed by a qualified representative of Jubilant and reasonably acceptable to Cadista, shall accompany each shipment to Cadista.  Title and risk of loss shall pass upon the loading of Product upon the ship at port of embarkation (or if not being transported by ship, then upon loading of carrier at place of manufacture).

6.4           Acceptance and Rejection of Products.

 

(a)           Cadista shall notify Jubilant in writing of its rejection of any Product supplied to it pursuant to this Agreement (“Rejection Notice”) as follows: (i) in the case of defects that are readily discoverable upon a physical inspection of a Product shipment, Cadista shall deliver a Rejection Notice within thirty (30) calendar days after Cadista or its designated facility has received such Product shipment, or (ii) in the case of a latent defect or any defect that was not obvious and could not be readily discovered from a physical inspection of the Product supplied (“Latent Defect”), Cadista shall deliver a Rejection Notice within thirty (30) calendar days of the date that Cadista discovers such defect.  The notification by customer or a returns processor  of a defect to Cadista shall be treated as the date of discovery and such defect shall be deemed a Latent Defect.  In the event the Failure to provide a Rejection Notice to Jubilant within the applicable 30-day period shall constitute acceptance by Cadista of the shipment, unless mutually agreed between the two parties. (“Accepted Product”).  Rejection Notices that are provided by Cadista shall state in reasonable detail (sufficient to enable Jubilant to identify the nature of the problem for tests or studies to be conducted by or on its behalf or to dispute the same) the reason why Cadista believes the Product does not conform to its Specifications and/or the Product warranties contained in Section 8.1.  Cadista shall, within fifteen (15) Business Days of the delivery by Cadista of any such Rejection Notice, provide samples of the Product being rejected, if appropriate, and copies of written reports relating to tests, studies or investigations performed to date by or on behalf of Cadista on the Product being rejected.

 

  

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(b)           Cadista’s test results or basis for rejection shall be conclusive unless Jubilant notifies Cadista within fifteen (15) Business Days of receipt by Jubilant of receipt of the above mentioned samples that it disagrees with such test results or basis for rejection. Jubilant may only assert a disagreement if it alleges that the defects were introduced by Cadista.  If Cadista and Jubilant fail to agree within fifteen (15) Business Days after Jubilant’s notice to Cadista as to whether any Product identified in the Rejection Notice deviates from the Product Specifications for such Product or fails to comply fully with the Product warranties contained in Section 8.1, representative samples of the batch of the Product in question, together with mutually agreed upon questions, shall be submitted to a mutually acceptable independent laboratory or consultant (if not a laboratory analysis issue) for analysis or review.  The results of such applicable independent evaluation shall be binding upon the Parties.  If Jubilant and Cadista determine by agreement, or if such evaluation certifies that the Product was properly rejected by Cadista, Cadista may reject the Product in the manner contemplated by Section 6.4(d).  The Party that is determined to have been incorrect in its determination of whether the Product complies fully with the Product Specifications and the Product warranties contained in Section 8.1 shall pay all of the costs of such independent evaluation, including, without limitation, laboratory fees and additional shipping and transportation costs.  Should the fees associated with the work conducted by the independent laboratory or consultant be due up front, Cadista and Jubilant shall each pay fifty percent (50%) of such upfront fees; provided, that if it is determined by the independent laboratory or consultant that either Party shall have been incorrect in its determination as to whether the Product complies fully with the Product Specifications and the Product warranties contained in Section 8.1, such incorrect Party shall reimburse the other Party for such fifty percent (50%) of such fees within ten (10) Business Days of such determination by the independent laboratory or consultant, as the case may be.

 

(c)          If any order of a Product is rejected by Cadista, Cadista’s obligation to pay Jubilant in respect of the rejected Product shall be suspended until such time as the rejection is determined or otherwise agreed to be incorrect per Section 6.4(b).  If only a portion of an order is rejected, only the duty to pay the amount allocable to such rejected portion shall be suspended.

 

(d)          In the event an order or partial order is rejected by Cadista pursuant to the provisions of this Section 6.4, the non-conforming shipment of a Product, or the non-conforming portion thereof, shall be held for Jubilant’s disposition, or shall be returned to Jubilant, in each case at Jubilant’s expense, as directed by Jubilant.  Jubilant shall use its Commercially Reasonable Efforts to replace the non-conforming shipment of such Product, or the non-conforming portion thereof, with conforming Product as soon as reasonably practicable after receipt of notice of rejection thereof, and in any event will do so within the later of forty-five (45) calendar days after receipt of notice of rejection thereof or thirty (30) calendar days of an independent testing decision in favor of Cadista, at no cost to Cadista.  Jubilant shall make arrangements with Cadista for the return or destruction, at Jubilant’s option and cost, of any rejected Product.  All such return shipping charges or costs of destruction shall be paid by Jubilant.  In the event that Cadista has paid for rejected Product, and such Product has not been satisfactorily replaced, Jubilant shall promptly extend a credit to Cadista for the full amount paid by Cadista for such Product, together with related costs, or dispute such claim and, if necessary, initiate dispute resolution in accordance with Section 6.4(b) of this Agreement.

 

  

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6.5           Product Recall.  In the event that either Party believes it may be necessary to conduct a recall, field correction, market withdrawal, stock recovery, or other similar action with respect to any Product which was sold under this Agreement (a “Recall”), Cadista and Jubilant shall promptly consult with each other in good faith as to how best to proceed, it being understood and agreed that the final decision as to any Recall of any Product sold by Cadista shall be made by Cadista; provided, however, that neither Party shall be prohibited hereunder from taking any action that it is required to take by Applicable Law.  Each of Jubilant and Cadista shall make a permanent, complete and accurate record of all costs incurred by it in connection with any Product recall.

 

(a)           With respect to any Recall or seizure of any Product sold by Cadista and caused by the negligence, mistake or omission of Jubilant, Jubilant shall (i) reimburse (or at Cadista’s option, credit) Cadista for all out-of-pocket costs and expenses reasonably incurred by Cadista in connection with the Recall or seizure, replacing the Product subject to the Recall or seizure in accordance with the provisions of Section 6.5; and (ii) as provided in Section 12.1(b), indemnify and save Cadista harmless from and against any and all damages to or claims by Third Parties associated with or resulting from any such Recall.

 

(b)          With respect to any Recall or seizure caused by the negligence, mistake or omission of Cadista, Cadista shall:  (i) reimburse (or at Jubilant’s option, credit) Jubilant for all out-of-pocket costs and expenses reasonably incurred by Jubilant in connection with the Recall or seizure; and (ii) as provided in Section 12.1(a), indemnify and save Jubilant and its Affiliates harmless from and against any and all damages to or claims by Third Parties associated with or resulting from any such Recall.

 

(c)           With respect to any Recall of a Product sold by Cadista and not caused by the negligence, mistake, fault, error or omission of either Party, the expenses shall be for the account of Jubilant.

 

(d)           If Jubilant and Cadista cannot agree which Party is at fault or whether a Recall or seizure was reasonably beyond the control of the Parties, then an independent technical expert, acceptable to both Parties, shall be designated to make such determination.  The so designated technical expert shall not be an employee, consultant, officer, director or shareholder of, or otherwise associated with, Jubilant, Cadista or their respective Affiliates.  The technical expert’s determination will be, in the absence of fraud or manifest error, binding and conclusive upon the Parties.

 

(e)           Each Party shall keep the other fully informed of any notification or other information, whether received directly or indirectly, which might affect the marketability, safety or effectiveness of a Product, or which might result in liability issues or otherwise necessitate action on the part of either party, or which might result in Recall or seizure of such Product.   Each Party shall reasonably cooperate with the other in the implementation of a Recall.

 

  

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(f)            Prior to any reimbursement pursuant to this Section 6.5 the Party claiming reimbursement shall provide the other party with all available documentation of all reimbursable costs and expenses.

 

6.6           Approved Manufacturer.

 

For each Product, Jubilant may, at any time during the Term, direct that a Product be manufactured by a Third Party manufacturer (an “Approved Manufacturer”).  In such event, Cadista shall purchase its requirements of such Product exclusively from such Approved Manufacturer under the same terms of this Agreement, so long as the Third Party manufacturer complies with all applicable regulations, including cGMP’s.

 

ARTICLE VII – PAYMENT OF PURCHASE PRICE;

ACCOUNTING

7.1           Product Purchase Price.  The purchase price payable by Cadista to Jubilant for each Product shall be ninety percent (90%) of the Net Sales of such Product (the “Product Purchase Price”).  At the time of delivery of a shipment of a Product to Cadista, Jubilant shall issue to Cadista an invoice for such shipment which will contain the estimated Product Purchase Price calculated based on the then current Expected Market Price for such Product.

7.2          Sales Reports.  Within ten (10) days after each calendar quarter, Cadista shall provide Jubilant a quarterly sales report for each Product.  The quarterly report shall show Product sales during each quarter by customer, including the calculation of the Net Sales for such Product for such quarter.  Cadista shall provide such other information relating to the sales of the Product as may reasonably be requested by Jubilant, from time to time.

7.3           Quarterly Adjustment.  Within thirty (30) days after each calendar quarter, Cadista shall calculate the actual Product Purchase Price of a Product for Net Sales occurring during such quarter giving effect to the actual Net Sales price for such Product during such quarter and the Destination Charges incurred in such quarter.  To the extent the estimated Product Purchase Price paid by Cadista to Jubilant for such Product during such quarter exceeds ninety percent (90%) of the Net Sales price for such Product, Jubilant shall issue to Cadista a credit for such overpayment which shall be applied against future Product purchases.  To the extent the estimated Product Purchase Price paid by Cadista to Jubilant for such Product during such quarter is less than ninety percent (90%) of the Net Sales price for such Product, such shortfall shall be added to the next Product invoice from Jubilant.  Jubilant shall also credit Cadista for Destination Charges incurred in a quarter by crediting such amount against future Product purchases.  Any amounts remaining to be credited by Jubilant to Cadista or to be included in a future invoice to Cadista at the termination or expiration of the Agreement shall be settled in cash at the termination or expiration of this Agreement.

 

  

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7.4           Payment Terms.  Cadista will pay to Jubilant the invoiced Product Purchase Price for each Product shipment within sixty (60) days from the date of receipt of invoice.  All payments hereunder shall be paid in United States dollars, by wire transfer to a bank account designated by Jubilant.

7.5           Jubilant’s Audit Rights.  Cadista shall maintain and Cadista shall require its Affiliates to maintain, at their respective offices, accurate and complete books and records of the Cadista Net Sales of each of the Products and in such form and in such reasonable detail as to enable Cadista to verify the Net Sales of each of the Products.  Upon the written request of Jubilant, and not more than once per calendar year, Cadista shall permit an independent certified public accounting firm selected by Jubilant and reasonably acceptable to Cadista to have access during normal business hours to such of the records of Cadista as may be reasonably necessary to verify the accuracy of the Net Sales and any deductions used to calculate Net Sales for each Product for any calendar year ending not more than three full years prior to the date of such request.  If such accounting firm concludes that there are discrepancies in the reporting or calculation of the Net Sales for a Product, such accounting firm shall recalculate such amounts and: (a) Cadista shall pay any additional sums underpaid to Jubilant within thirty (30) calendar days of such re-determination; or (b) Jubilant shall credit Cadista for any overpaid amounts.  The fees and expenses charged by such accounting firm shall be paid by Jubilant.  However, if the audit discloses that the aggregate payments relating to all Products to Jubilant was underpaid during the audit period by more than $25,000, then Cadista shall pay the reasonable fees and expenses charged by the accounting firm.  The results of such audit shall be final and binding on the Parties.

7.6           Sales and Use Taxes.  Cadista shall be responsible for the payment of all federal, state or local taxes, use or value added taxes, excise or similar charges, or other tax assessments (other than that assessed against income), assessed or charged on the sale of the Products by Cadista in the  Territory pursuant to this Agreement.

7.7           Confidential Financial Information.  The Parties shall treat all financial information subject to review under Section 7.5 hereof as Confidential Information.

7.8           Unsold Product and Product Returned by Customer.    Cadista may return for a full refund Product which it was not able to sell, when the Product’s remaining shelf life reaches twelve months or less (even though when received shelf life was longer), or when it reasonably determines that it will not be able to sell Product within three (3) months.  In lieu of adjusting Net Sales, Cadista may return for a full refund any Product returned by a customer.  All refunds shall include Destination Charges, in addition to Product Purchase Price.  Jubilant shall bear all expenses of any returns under this Section 7.8, including without limitation, transportation, customs and taxes.  In the event Jubilant requests the destruction of Product in lieu of return, Jubilant shall bear all expenses of such destruction and refund amounts paid for such Product and any Destination Charges.

 

  

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ARTICLE VIII

MANUFACTURING STANDARDS AND QUALITY ASSURANCE

 

8.1           Jubilant Product Warranties.  Jubilant hereby represents, warrants, covenants and agrees that:

(a)           All Products supplied to Cadista by Jubilant under this Agreement (i) will meet the Product Specification for such Product as of the date that title to such Product is delivered to Cadista and during the shelf life of such Product, (ii) will satisfy Applicable Laws and cGMP with respect to the manufacture, packaging, storage and shipment of such Product, and (iii) will not be adulterated or misbranded pursuant to Sections 501 and 502 of the FD&C Act (21 U.S.C. §§ 351 & 352).

 

(b)          All Products supplied by Jubilant hereunder will be transferred to Cadista free and clear of any liens, claims, encumbrances and security interests.

 

(c)           The Product supplied by Jubilant shall have a shelf life of at least 21 months at the time it is received by Cadista.

 

8.2           Jubilant General Warranties.

(a)           Jubilant is not debarred and will not to its knowledge use in any capacity the services of any Person debarred under Section 335(a) of the FD&C Act; and

 

(b)           Except as otherwise provided in this Agreement, Jubilant shall obtain and maintain all necessary licenses, permits or approvals required by the FDA or other relevant Governmental Authority in connection with the manufacture, filling, packaging, storage, and shipment of the Products, including, without limitation, all material permits related to its manufacturing facility.

 

8.3           Product Testing. Jubilant shall conduct, or cause to be conducted, all physical parameters and in-process testing with respect to each batch of a Product to be supplied pursuant hereto prior to delivery thereof to Cadista.  Jubilant shall retain a sample of each batch tested for at least the shelf life of such batch, or such longer period as may be required by cGMP.

 

8.4           Disclaimer.  JUBILANT HEREBY DISCLAIMS ALL WARRANTIES NOT EXPRESSLY PROVIDED IN THIS AGREEMENT, INCLUDING ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE AND WARRANTIES OF MERCHANTABILITY.

 

  

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ARTICLE IX

TERM, EXCLUSIVITY AND TERMINATION

 

9.1           Term.  This Agreement shall commence on the Effective Date and, unless sooner terminated pursuant to Section 9.2, shall continue in full force and effect on a Product-by-Product basis for a term of five (5) years from the date of the first commercial sale of such Product in the Territory (the “Initial Term”); provided, however, that the Initial Term shall be extended automatically for additional terms of one (1) year each thereafter (each a “Renewal Period”) in the absence of either Party providing written notice to the other electing not to renew the Term of this Agreement with respect to a Product, which written notice shall be provided by such Party to the other not later than one hundred and eighty (180) days prior to the expiration of the Initial Term or any Renewal Period (the Initial Term and any Renewal Period for a Product are referred to collectively as the “Term” and shall be determined on a Product-by-Product basis).

9.2           Termination.  (a) Prior to the expiration of the Term, this Agreement may be terminated in its entirety for all Products:

(i)          immediately upon the mutual written consent of Cadista and Jubilant;

 

(ii)         by either Party upon the other Party’s  material breach of its obligations under this Agreement, which material breach remains uncured sixty (60) calendar days after the terminating Party has provided written notice of same; or

(iii)        in the event either Party ceases conducting business in a normal course, becomes insolvent, makes a general assignment for the benefit of creditors, suffers or permits the appointment of a receiver for its business or assets, or avails itself of, or becomes subject to, any case or proceeding under the Bankruptcy Code or any other statute of any state or country relating to insolvency or the protection of creditor rights, or otherwise rejects this Agreement in any case or proceeding under the Bankruptcy Code, the other Party shall have a right to terminate this Agreement, provided that in the case of an involuntary bankruptcy proceeding such right to terminate shall only become effective if the other Party consents thereto or such proceeding is not dismissed within ninety (90) calendar days after the filing thereof.  The Parties agree that each party may fully exercise all of its rights and elections under the Bankruptcy Code.

(b)         This Agreement may be terminated with respect to a Product or Products upon the mutual written consent of the Parties with respect to such Product or Products.

9.3 Rights and Remedies upon Termination of Agreement. (a) In the event this Agreement is terminated under Section 9.2(a) or upon the expiration of the Term: (1) the marketing, distribution and sales rights granted to Cadista for the Products shall terminate; (2) Jubilant’s obligations to manufacture and supply the Products to Cadista, and Cadista’s obligation to source the Products exclusively from Jubilant, shall terminate; (3) Cadista may sell all of the Products in its possession or ordered prior to the effective date of such termination, provided that Cadista remits to Jubilant, the Product Purchase Price for such Products in accordance with Sections 7.1 and 7.3; and (4) any Regulatory Approvals relating to Products (including, without limitation, the ANDAs relating to the Products) and any Intellectual Property Rights belonging to Jubilant will remain the sole and exclusive property of Jubilant.

 

  

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(b)          In the event this Agreement is terminated under Section 9.2(b), (1) the marketing, distribution and sales rights granted to Cadista for the affected Product shall terminate; (2) Jubilant’s obligations to manufacture and supply the affected Products to Cadista, and Cadista’s obligation to source the affected Products exclusively from Jubilant, shall terminate; (3) Cadista may sell all of the affected Products in its possession or ordered prior to the effective date of such termination, provided that Cadista remits to Jubilant the Product Purchase Price for such affected Products in accordance with Sections 7.1 and 7.3; and (4) any Regulatory Approvals relating to the affected Products (including, without limitation, the ANDAs relating to the Products) and any Intellectual Property Rights belonging to Jubilant will remain the sole and exclusive property of Jubilant.

9.4           Survival.  (a) Upon termination of this Agreement, it shall forthwith become void and of no further force or effect, except for the following provisions, which shall remain in full force and effect: (a) Section 6.5 (Product Recall); (b) Article VII  (Payment of Marketing Commission; Product Purchase Price; Accounting); (c) Article XII (Indemnification); (d) Article X (Confidentiality), (e) Section 9.3 (Rights and Remedies Upon Termination); (f) this Section 9.4 and (g) Article XIII.  The rights and remedies provided in this Article IX shall be cumulative and not exclusive of any rights or remedies provided by Applicable Law.

(b) Any termination of this Agreement shall not affect any right or claim hereunder that arises prior to such termination, which claims and rights shall survive any such termination, including, without limitation, any claim for indemnification under Article XII.  In addition, at Jubilant’s option, Cadista all take delivery and pay for all Product subject to outstanding purchase orders at the time of termination.

ARTICLE X – CONFIDENTIALITY

10.1        Confidentiality and Non-Use Obligations.  (a)  During the Term of this Agreement and for five (5) years thereafter without regard to the means of termination, neither Cadista nor Jubilant shall use, for any purpose other than the purpose of this Agreement, reveal or disclose to any Third-Party information and materials disclosed by the other Party (whether prior to or during the Term of this Agreement), and marked as confidential or for which the receiving Party knows or has reason to know are or contain trade secrets or other proprietary information of the other Party (the “Confidential Information”) without first obtaining the written consent of the other Party.

 

(b)         The Parties shall take all reasonable precautions to prevent the use or disclosure of such Confidential Information without first obtaining the written consent of the other Party, except (i) as may be required for securing Regulatory Approval, or as may otherwise be required to be disclosed to an Agency in the Territory; or (ii) as required in connection with any filings made by the Securities and Exchange Commission or similar non-U.S. regulatory authorities or by the disclosure policies of a major stock exchange.

 

  

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(c)         These restrictions upon disclosure and use of Confidential Information shall not apply to any specific portion of Confidential Information which:

	
  

	
(i)

	
is Confidential Information which can be demonstrated by the recipient’s documentary evidence to have already been in the possession of the recipient at the time of disclosure by the other Party;

	
  

	
(ii)

	
is or later becomes available to the public, as evidenced by documents which were generally published, other than by a breach by the Party;

	
  

	
(iii)

	
is received from a Third Party having legitimate possession thereof and the independent legal right to make such disclosure;

	
  

	
(iv)

	
is information developed by the Party entirely without reference or use of Confidential Information, as established by probative documentary evidence; or

	
  

	
(v)

	
is required to be disclosed by law or government regulation.

ARTICLE XI – REPRESENTATIONS, WARRANTIES AND COVENANTS

           11.1            Legal and Governmental Compliance.  Each Party shall comply with all Applicable Laws, relating to the activities undertaken by such Party hereunder.

           11.2           Jubilant Representations, Warranties and Covenants.  Jubilant represents, warrants and covenants  to Cadista that the following are true and correct as of the date stated therein, or if none is specified then as of the  date hereof:

	
  

	
(a)

	
Jubilant is a corporation duly organized, validly existing, and in good standing under the applicable laws of incorporation and has full corporate power to own its properties and conduct the business presently being conducted by it, and is duly qualified to do business in, and is in good standing under, the laws of all states and nations in which its activities or assets require such status, except in any case where the failure to be so qualified and in good standing would not be material.

	
  

	
(b)

	
Jubilant has full corporate right, power and authority to perform its obligations pursuant to this Agreement, and this Agreement and the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action on the part of Jubilant. This Agreement has been duly and validly executed by Jubilant.

 

  

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(c)

	
To the best of Jubilant' knowledge, it has not and will not use the services of any persons debarred under 21 U.S.C. § 335(a) or (b) in any capacity associated with or related to the manufacture of the Products including those of its contract manufacturers.

            11.3           Representations, Warranties and Covenants of Cadista.

Cadista represents, warrants and covenants  to Jubilant that the following are true and correct as of the date stated therein, or if none is specified then as of the  date hereof:

	
  

	
(a)

	
Cadista is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has full corporate power to own its properties and conduct the business presently being conducted by it, and is duly qualified to do business in, and is in good standing under, the laws of all states in which its activities or assets require such status, except in any case where the failure to be so qualified and in good standing would not be material.

	
  

	
(b)

	
Cadista has full corporate right, power and authority to perform its obligations pursuant to this Agreement, and this Agreement and the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action on the part of Cadista. This Agreement has been duly and validly executed by Cadista.

	
  

	
(c)

	
Without limiting anything herein, Cadista shall comply with all Applicable Laws in performing this Agreement, including all marketing, promotional or advertising activities.

	
  

	
(d)

	
Cadista is not debarred and will not to its knowledge use in any capacity the services of any Person debarred under Section 335(a) of the FD&C Act.

	
  

	
(e)

	
Except as otherwise provided in this Agreement, Cadista shall obtain and maintain all necessary licenses, permits or approvals required by the FDA or other relevant Governmental Authority in connection with the marketing, distribution and sale of the Products in the Territory.

           11.4          Limitation on Warranties.  Except as expressly provided in this Agreement, neither Party makes any representation or warranty to the other, whether express or implied, either in fact or by operation of law, by statute or otherwise, and both Parties specifically disclaim any and all implied or statutory warranties, including, without limitation, any warranty of merchantability or warranty of fitness for a particular purpose.  In addition, each Party understands and agrees that neither Party warrants nor commits that the Product will be successfully developed, be submitted for applicable Regulatory Approval, or receive applicable Regulatory Approval.

 

  

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ARTICLE XII - INDEMNIFICATION; INSURANCE

12.1       Indemnification.  (a) Cadista Indemnification.  Cadista agrees to indemnify and hold forever harmless Jubilant and its Affiliates and each of their agents, directors, officers and employees from and against any third-party loss, damage, action, proceeding, expense or liability (“Losses”) arising from or in connection with (i) the offer for sale, sale or distribution by Cadista in the Territory of a Product, except for Losses to the extent Jubilant has agreed to indemnify Cadista pursuant to Section 12.1(b);  (ii) infringement or misappropriation of any copyright or trademark arising out of the marketing and/or sale of a Product in the Territory during the Term; (iii) the breach or inaccuracy of any representations, warranties or covenants made by Cadista in this Agreement; and (iv) a Recall described in Section 6.5(b).

(b)         Jubilant Indemnification.  Jubilant agrees to indemnify and hold forever harmless Cadista and each of their agents, directors, officers and employees from and against any Losses arising from or in connection with: (i) the breach or inaccuracy of any representations, warranties or covenants made by Jubilant in this Agreement; (ii) Jubilant’s or its Affiliates’ manufacture and supply of a Product that does not meet Product Specifications or such Product Warranties provided in Section 8.1 at the time of delivery and during the shelf life of such Product; (iii) the infringement or misappropriation of any patent or trade secret of any Third Party relating to any Product; (iv) Service Level Charges; (v) Destination Charges;  and (vi) a Recall described in Section 6.5(a) and Section 6.5(c).

12.2        Procedure; Limitation of Liability. The indemnities set forth in this Article XII are subject to the condition that the Party seeking indemnity shall forthwith notify the other Party on being notified or otherwise made aware of a suit, action or claim and that the indemnifying Party defend and control any proceedings, with the other Party being permitted to participate at its own expense (unless there shall be a conflict of interest which would prevent representation by joint counsel, in which event the indemnifying Party shall pay for the reasonable costs of other Party’s counsel, to be selected by the indemnifying Party upon consent of the other Party, not unreasonably withheld); provided that the indemnifying Party may not settle the suit or otherwise consent to any judgment in such suit without the written consent of the indemnified Party (such consent not to be unreasonably withheld or delayed).  The Parties shall cooperate in the defense of any Third Party claim.  The Parties acknowledge and agree that the indemnity provisions of Section 12.1 shall comprise the Parties’ sole and exclusive remedy at law or equity for matters relating to the subject matter of this Agreement.  Notwithstanding anything to the contrary contained herein, Cadista’s liability to Jubilant  for indemnification and/or breach of this Agreement is limited to $250,000 in the aggregate.

12.3       Other Product Liability Claims.  To the extent either party incurs any Losses arising from or in connection with any claim based on product liability with respect to the Product to the extent not arising from the actions set forth in Sections 12.1(a) and 12.1(b), above (“Product Claim”) such Losses shall be borne by Jubilant.

 

  

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12.4        DISCLAIMER.  NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY COVER, SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES OR EXPENSES, INCLUDING WITHOUT LIMITATION DAMAGES FOR LOST PROFITS, LOSS OF OPPORTUNITY OR USE OF ANY KIND, SUFFERED BY THE OTHER PARTY, WHETHER IN CONTRACT, TORT OR OTHERWISE.

12.5        Insurance.  During the term of this Agreement and for a period of five (5) years after its expiration or earlier termination, each Party shall obtain, at its sole cost and expense, liability insurance applicable to its performance under this Agreement, which meets the following requirements:

(a)         the insurance shall insure such Party against all liability related to its activities relating to the development, manufacture or sale of a Product (whether such Party’s liability arises from its own conduct or by virtue of its participation in this Agreement), including liability for bodily injury, property damage, wrongful death, and any contractual indemnity obligations imposed by this Agreement; and

(b)        the insurance shall be in amounts that are reasonable and customary in the United States in the pharmaceutical industry, but in no event shall liability insurance relating to manufacture, sale or distribution of a marketed product maintained by such Party cover less than the greater of (i)  ten million U.S. dollars (U.S. $10,000,000) per occurrence (or claim) and an annual aggregate of ten million U.S. dollars (U.S. $10,000,000) or (ii) such limits required to be maintained by Cadista as mandated by Cadista’s customers.  All such policy shall include a contractual endorsement naming the other Party to this Agreement as an additional insured and require the insurance carriers to provide such other Party with no less than thirty (30) days’ written notice of any change in the terms or coverage of the policies or their cancellation.

 

ARTICLE XIII - MISCELLANEOUS

13.1        Force Majeure. Neither Party shall lose any rights hereunder or be liable to the other Party for damages or Losses on account of failure of performance by the defaulting Party if the failure is occasioned by government action, war, fire, explosion, flood, strike, lockout, embargo, act of God, or any other similar cause beyond the reasonable control of the defaulting Party, provided that the Party claiming force majeure has exerted all reasonable efforts to avoid or remedy such force majeure and given prompt notice to the other Party.

13.2        Notices.  All notices or other communications given pursuant hereto by one Party hereto to the other Party shall be in writing and shall be deemed given (a) when delivered by messenger, (b) when sent by telecopier (with receipt confirmed), (c) when received by the addressee, if sent by express mail, federal express or other express delivery service (receipt requested) or (d) three (3) days after being mailed in the U.S., first-class postage prepaid, registered or certified, in each case to the appropriate addresses and telecopy number set forth below (or to such other addresses and telecopy numbers as a Party may designate as to itself by notice to the other Party):

 

  

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Notices for Jubilant shall be sent to:

Jubilant Life Sciences Ltd.

Plot No 1-A, Institutional Area,

Sector 16/A Noida 201 301,

Uttar Pradesh, India

Attn: President

Notices for Cadista shall be sent to:

Jubilant Cadista Pharmaceuticals Inc.

207 Kiley Drive

Salisbury, Maryland   21801

Attn: President

13.3        Governing Law.  This Agreement shall be governed by the laws of the State of New York, as such laws are applied to contracts entered into and to be performed within such state, as though made and to be fully performed therein without regard to conflicts of law principles thereof.  The United Nations Convention on Contracts for the International Sale of Goods will not apply to this Agreement.

13.4        Non-waiver of Rights.  Except as specifically provided for herein, the waiver from time to time by any of the Parties of any of their rights or their failure to exercise any remedy shall not operate or be construed as a continuing waiver of same or of any other of such Party’s rights or remedies provided in this Agreement.

13.5        No Agency.  Neither Party shall by virtue of this Agreement have any power to bind the other to any obligation nor shall this Agreement create any relationship of agency, partnership or joint venture.

13.6        Severability. If any term, covenant, or condition of this Agreement or the application thereof to any Party or circumstance shall, to any extent, be held to be invalid or unenforceable, then (i) the remainder of this Agreement, or the application of such term, covenant or condition other than those as to which it is held invalid or unenforceable, shall not be affected thereby and each term, covenant, or condition of this Agreement shall be valid and be enforced to the fullest extent permitted by law and (ii) the Parties hereto covenant and agree to renegotiate any such term, covenant, or application thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant, or condition of this Agreement or the application thereof that is invalid or unenforceable.

 

13.7        Entire Agreement. This Agreement together with the Exhibits and Schedules hereto sets forth all the covenants, promises, agreements, warranties, representations, conditions, and understandings between the Parties hereto in the scope of the collaboration, and supersedes and terminates all prior agreements and understanding between the Parties under this Agreement. No subsequent alteration, amendment, change, or addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of the Parties.

 

  

  

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13.8        Assignment. No Party shall, without the prior written consent (not to be unreasonably withheld or delayed) of the other Party having been obtained, assign or transfer this Agreement to any Third-Party, provided, however, that any Party may assign or transfer this Agreement to any Affiliate, provided that the assigning Party shall guarantee the performance of that Affiliate, or to any successor by merger of such Party of its pharmaceutical business, or to the Purchaser of all or substantially all of such assets of, or stock relating to, its pharmaceutical business, without the prior written consent of the other Party hereto.  This Agreement shall be binding upon and shall inure to the benefit of the Parties and their successors and permitted assigns.

13.9        Facsimile Execution.  This Agreement may be executed in facsimile-signature counterparts, including PDF/email, each of which is hereby agreed to have the legal binding effect of an original signature.  The Parties hereto agree to forward the original signatures by overnight mail to the other Party upon execution, if requested.

13.10    Third Party Beneficiaries. This Agreement has no intended third party beneficiaries.

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the day and year first indicated above.

	
JUBILANT LIFE SCIENCES LTD.

	  	
JUBILANT CADISTA PHARMACEUTICALS INC.

	  	  	  	  
	
BY:

	        /s/ Neeraj Agrawal	  	
BY:

	
/s/ Kamal Mandan

	  	
NAME :Neeraj Agrawal

	  	  	
NAME :Kamal Mandan

	  	
TITLE:  CEO Generics

	  	  	
TITLE:  Chief Financial Officer

 

  

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SCHEDULE 1

Products

	
Product

	  	
Innovator Product

	  	
Dosage Form

	
Lamotrigine Chew Tablets

	  	
Lamictal

	  	
5 and 25 mg tablets

	
[***]

	  	
[***]

	  	
[***]

	
[***]

	  	
[***]

	  	
[***]

	
[***]

	
  

	
[***]

	
  

	
[***]

 

Amendments to the foregoing table shall be evidenced by the signatures below.

 

	
JUBILANT LIFE SCIENCES LTD.

	 	
JUBILANT CADISTA PHARMACEUTICALS INC.

	  	 	  
	
BY:

	  	 	
BY:

	  
	  	
NAME :

	 	
`

	
NAME :

	  	
TITLE:

	 	  	
TITLE:

	  	
DATE:

	 	  	
DATE:

 

[***Confidential treatment requested pursuant to a request for confidential treatment filed with the

Securities and Exchange Commission. Omitted portions have been separately filed with the Commission.]

 

  

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EXHIBIT A

PRODUCT SPECIFICATIONS

See Attached

 

[***Confidential treatment requested pursuant to a request for confidential treatment filed with the

Securities and Exchange Commission. Omitted portions have been separately filed with the Commission.]

 

  

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[*** Four Pages of Product Specification Have Been Omitted]

 

 

[***Confidential treatment requested pursuant to a request for confidential treatment filed with the

Securities and Exchange Commission. Omitted portions have been separately filed with the Commission.]

 

  

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Specifications for each Product are to be established as set forth in the definition of Product Specifications.  Amendments to Product Specifications shall be evidenced by the signatures below.

	
JUBILANT LIFE SCIENCES LTD.

	 	
JUBILANT CADISTA PHARMACEUTICALS INC.

	  	 	  
	
BY:

	
 

	 	
BY:

	
 

	  	
NAME :

	 	  	
NAME :

	  	
TITLE:

	 	  	
TITLE:

 

  

25

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