EXHIBIT No. 216 ROCHE-ORGANON, INC., Nutley, New Jersey. SCHERING CORPORATION, Bloomfield, N. J., December 28, 1939. DEAR SIRS: Article 8 (b) of the Agreement between us dated December 28, 1939, relating to Male Hormones provides that sales in bulk of any of the products mentioned may be made to others when written consent of both of us is first obtained. We hereby confirm that each of us consents that either of us may sell the products mentioned in the said agreement in bulk to any persons or firms which are acting under the protection of foreign patents corresponding to the "Patents" as defined in the said agreement. The right to sell such products to others shall not however be construed to permit the sale of such products in bulk in the United States, its territories, or possessions; nor shall the right hereby granted authorize or permit the import of the products so sold into the United States, its territories or possessions without the payment of royalties thereon as provided in the said agreement. It is further agreed that no royalties are payable by you on sales of the licensed products to licensees under the "Patents" nor on sales to others who are acting under the protection of the foreign patents corresponding to the said United States patents. In confirmation of the above, we request that you sign and return to us the enclosed copy of this letter. (Male Hormones) SCHERING CORPORATION AND ROCHE-ORGANON, INC.-LICENSE AGREEMENT DECEMBER 28, 1939. AGREEMENT dated July 1, 1938 between SCHERING CORPORATION, a New Jersey corporation with its head office at Bloomfield, New Jersey (the Licensor) and ROCHE-ORGANON, INC., a New Jersey corporation with its head office at Nutley, New Jersey (the Licensee). WHEREAS the Licensor is the sole owner of the letters patent and applications for letters patent of the United States set forth in Schedule A annexed hereto; and WHEREAS the Licensee wishes to acquire from the Licensor a license on the terms and conditions hereinafter stated. NOW, THEREFORE, the parties hereto, each in consideration of the covenants of the other herein contained, hereby agree as follows: 1. Whenever used in this agreement the term "the Patents" means not only the patents and the applications listed in Schedule A annexed hereto, but also all other United States patents and applications therefor in the male sex hormone field that may hereafter on or before December 31, 1954, be issued to or acquired by the Licensor or in which the Licensor shall have the right to grant a license coterminous with the license hereby granted. 2. (a) The Licensor hereby grants to the Licensee upon the terms and conditions hereinafter stated a nonexclusive nonassignable license to manufacture, use, and sell the products described and claimed in the Patents and to practice the processes described and claimed therein throughout the United States of America, its territories and possessions, but only in the male sex hormone field, for a period beginning July 1, 1938 and ending at the end of the term for which the last expiring of the Patents is or shall be granted, or sooner as hereinafter provided. (b) All United States patents and applications therefor in the male sex hormone field that shall be hereafter issued to or otherwise acquired by the Licensor or in which the Licensor shall hereafter acquire any right, title, or interest shall be promptly disclosed by the Licensor to the Licensee and upon such disclosure by the Licensor to the Licensee shall without more forthwith. come under the license hereby granted. 3. (a) Neither party hereto shall, without the written consent of the other party first obtained in each instance, give any license or sublicense, or any right of exploitation covering any of the products of the Patents or of the processes relating thereto, except that the Licensor may without the Licensee's consent grant any such licenses and rights to Ciba Pharmaceutical Products, Inc., Summit, New Jersey, and to Rare Chemicals, Inc., Nepera Park, New York, or either of them. (b) The Licensee shall manufacture under this license only in its own plant or plants located in the U. S. A. and distribution of products under this license shall be made only by the Licensee and only under a single corporate name and/or trade name. (c) The Licensor shall pay unto the Licensee during the period commencing January 1, 1939, and ending December 31, 1954, 13% % of all the royalties received by the Licensor from all licenses granted under the Patents to others than the Licensee and said Ciba Pharmaceutical Products, Inc., and said Rare Chemicals, Inc. 4. (a) The Licensee shall pay unto the Licensor a royalty or license fee of six percent (6%) of the Licensee's turn-over in the United States during the period commencing January 1, 1939, and ending December 31, 1954, of all products and preparations containing male sex hormones. (b) The "male sex hormone field" includes all products and preparations containing male sex hormones of natural or synthetic origin and/or such substances as increase their effectiveness (activators), but activators only insofar as used as such. "Male sex hormones" mean hormones of the storol series, as, for instance, androsterone or testosterone, or their derivatives, as well as any materials having similar effects, and materials with physiological and clinical effects analogous to those of testosterone and androsterone insofar as they may be used therapeutically like testosterone and androsterone, and all materials derived from the male sex organs, but not materials and compounds with prevailing cortin or female hormone character and not aphrodisiacs like yohimbine, and not prolan or other like materials derived from urine or serum, and not prolan-like extracts from the hypophysis or other organs. (c) The Licensor's right to royalties on such turn-over shall not depend on whether or not the processes described and claimed in said letters patent is used for the manufacture of male sex hormone products or preparations, and shall not depend on whether or to what extent patent protection shall be maintained for said products or preparations in the United States of America, its territories and possessions. (d) The turn-over subject to royalty shall be determined by deducting from the sum of all invoices sent out by the Licensee during the said period (whether such invoices are paid or not) the cost of the outer shipping or mailing containers and ordinary trade discounts incurred, allowed, or paid by Licensee; and stamp taxes and other public taxes directly imposed on the sale of said products; but no commissions, cost of distribution, overhead, and any other deduction of any kind or nature whatsoever shall be made in determining the turn-over. Should the Licensee not distribute said products, in whole or in part, directly to the trade, or physicians, or hospitals, but distribute the same, in whole or in part, through its agent, the turn-over shall be computed on the basis of the invoices of such agents to such agents' customers and not on the invoice prices of the Licensee. (e) No royalty shall be payable on the Licensee's turn-over of its present preparation "Hombreol," but royalties shall be payable on "Neo-Hombreol" and on any preparation that constitutes a modification or alteration of “Hombreol" in its present form. 5. (a) The Licensee shall render to the Licensor at the end of each quarter of each calendar year a statement setting forth separately for each product for each month of said quarter the royalty and the turn-over for each such quarter, which statement shall contain an itemization of the specific deductions allowed. Each of such statements shall be supplied to the Licensor within 14 days after the end of each quarter. Royalties shall be paid on or before the 14th day after each such statement is due. (b) The Licensor shall render to the Licensee within a reasonable time after the end of each calendar year a statement showing the turn-over of the Licensor of the male hormone products for such calendar year. The Licensee shall keep on file accurate records of its sales and shall permit such records and its books of account to be inspected at all reasonable times by reputable certified public accountants representing but not regularly employed by the other party; but such accountants shall not have access to accounts pertaining to matters not covered by this agreement and the extracts or notes taken by them shall relate exclusively to the subject matter of this agreement and shall contain no reference to names or addresses of customers or to extraneous matters. If the inspection by the accountants show that the statement given is incorrect, the Licensee is obligated to compensate for all expenses and costs of the accountants, but when the inspection shows that the statement given is correct, these expenses and costs are to be charged to the Licensor. 7. Each party hereto shall forthwith upon making, discovering, conceiving, or otherwise acquiring any other processes, whether secret or not, or any formulae, or any technical, clinical, experimental, and manufacturing data, and any other discoveries in the field of this agreement, disclose the same forthwith to the other party hereto and shall assist the other party in every way in the application and further development thereof; provided, however, that neither party shall be obligated to disclose to the other any information regarding its costs of manufacture, production, or distribution. 8. (a) Subject to the provisions of paragraph (b) of this Article 8, neither party shall sell or offer for sale any product made pursuant to any of the process claims of the Patents or any product coming within the product claims of the Patents, excepting in a form ready for use by the consumer, completely packed and packaged under its own name or trade-mark, nor shall either party sell or offer for sale or deliver, directly or indirectly, any product made pursuant to any of the process claims of the Patents or Applications or any product coming within any of the product claims of the Patents or Applications, to others for use by them in putting up such products in commercial form for resale by them, nor sell the said product in bulk. (b) The provisions of paragraph (a) of this Article 8 shall not apply to sales by the Licensor or the Licensee of any of the products mentioned therein to licensees under the Patents, nor shall such provisions apply to sales to others when written consent of both parties is first obtained. 9. (a) The Licensee shall cooperate with the Licensor to defend the rights under the Patents, including interferences and attacks of third parties upon the validity of the Patents. (b) The Licensee shall not do any act or thing which might lessen or endanger said protection or unfavorably affect the full enjoyment of the Licensor's and Licensee's rights in and to said products and processes. (c) The cost of prosecuting any actions instituted by the Licensor for infringement of any Letters Patent covered by this license and the cost of defending any suit instituted against any of the patents and applications shall be borne 86%% by the Licensor and 13% % by the Licensee. 10. If and whenever either party hereto shall be in default in complying with any of the applicable terms of this agreement and the default shall continue unremedied or be repeated during a period of thirty days after the other party hereto shall have given to the defaulting party written notice specifying the default, then upon the expiration of the thirty-day period the party giving the notice of default shall have the right at its option to terminate this agreement and the license hereby granted by giving to the other party in default written notice to that effect; whereupon this agreement and the license hereby granted shall terminate forthwith, except that the party in default shall not thereby be discharged from any liability to the other party for damages or loss resulting from the default. 11. If a petition in bankruptcy or proceedings under the Bankruptcy Law shall be filed by or against Licensee, or if a receiver or trustee shall be appointed for the property of Licensee, or if the Licensee shall make a general assignment or take the benefit of any insolvent act, or upon the liquidation or dissolution of Licensee, then, and upon the happening of any of the foregoing contingencies, the Licensor may at its option terminate this agreement and the license hereby granted by giving to the Licensee written notice to that effect; whereupon this agreement and the license hereby granted shall terminate forthwith. 12. On December 31, 1954, this agreement, if then in force, shall terminate, except that the Licensee, if not then in default, shall continue to have a free license to manufacture, use, and sell under the Patents until the expiration of the last now or hereafter granted patent under which the Licensee is hereby licensed. 13. Upon any termination of this agreement and the license hereby granted, the parties hereto shall nevertheless remain liable for the payment of any royalties (also in accordance with Article 3, paragraph C) due and accrued up to the date of termination; and, if the termination occurs prior to December 31, 1954, the Licensee may for not longer than six months after termination continue to sell, subject to the provisions of this agreement and to the payment of any appli cable royalties, such licensed products as the Licensee shall have had on hand and ready for delivery at the date of termination. 14. For all purposes of this agreement any notice required or permitted to be given to a party hereto shall be effectively given if directed to the party at its last-known head office and sent by registered mail. 15. The Licensee accepts the license hereby granted and agrees to comply with all the conditions of this agreement requiring compliance on the part of the Licensor. 16. The Licensor agrees to comply with all the conditions of this agreement requiring compliance on the part of the Licensor. 17. If any one or more provisions of this agreement shall be or become unenforceable, all other provisions shall nevertheless continue in full force and effect. IN WITNESS WHEREOF, the parties hereto have executed this agreement in duplicate as of the date first above written. STATE OF NEW JERSEY, County of Essex, ss: ROCHE-ORGANON, INC., By E. H. BOвST, President. SCHERING CORPORATION, By J. WELTZEIN, President. On this 29th day of December 1939, before me personally came J. Welzein, to me known, who being by me duly sworn, did depose and say: That he resides at 25 Woodfield Dr. Short Hills, N. J.; that he is President of SCHERING CORPORATION, the corporation described in and which executed the foregoing instrument; that he knows the seal of said corporation; that the seal affixed to said instrument is such corporate seal; that it was so affixed by order of the Board of Directors of said corporation and that he signed his name thereto by like order. ORDINE C. FERRIS, Notary Public of N. J. My Commission Expires May 29, 1941. STATE OF NEW JERSEY, County of Essex, ss: On this 29th day of December 1939, before me personally came E. H. Bobst, to me known, who being by me duly sworn, did depose and say: That he resides at Lloyd Road, Montclair, N. J.; that he is President of ROCHE-ORGANON, INC., the corporation described in and which executed the foregoing instrument; that he knows the seal of said corporation; that the seal affixed to said instrument is such corporate seal; that it was so affixed by order of the Board of Directors of said corporation and that he signed his name thereto by like order. JOHN MORNY, Notary Public of N. J. My Commission Expires July 10, 1944. Schedule A.-Roche-Organon, Schering male hormones UNITED STATES APPLICATIONS Ser. No. Filing date Inventor Title Production of the Male Sexual Hormone. Esters of Polycyclic Alcohols and a Method Degradation Products of Sterols and a Method of Producing the Same. Saturated Degradation Products of Sterols Derivatives of Androstenols and a Method Acids of the Cyclopentane Polyhydro Unsaturated Compounds Containing a Compounds of the Androstane and Pregnane Series and Methods of Producing the Same. Steroid Compounds and a Process of Pro- Production of the Male Sexual Hormone. Process for the Manufacture of 4.5-Andro- SCHERING CORPORATION, Bloomfield, N. J. EXHIBIT No. 218 ROCHE-ORGANON, INC., Roche Park, Nutley, N. J., December 28, 1939. DEAR SIRS: Article 7 of the Agreement between us dated December 28, 1939, relating to Cortin provides that sales in bulk of any of the products mentioned may be made to others when written consent of both of us is first obtained. We hereby confirm that each of us consents that either of us may sell the products mentioned in the said agreement in bulk to any persons or firms which are acting under the protection of foreign patents corresponding to the "Patents" as de |